Smith & Nephew is recalling certain Tandem Bipolar Hip Replacement Systems due to a manufacturing defect that could cause the hip implant to break suddenly and require surgery.
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Smith & Nephew manufactures the Tandem Bipolar Hip System, an orthopedic implant used in partial hip replacement surgery.
Recall and Hazard Alert
September 12, 2016 — Smith & Nephew has issued a Hazard Alert for specific batches of the Tandem Bipolar Hip System and is recalling unused stock of the devices because the implant could detach after surgery.
Revision Surgery Due to Parts Becoming Detached
The problem is that the retainer groove may be out-of-specification on some devices. This could lead to three possible failure scenarios:
- Device does not assemble properly
- Head is too tight and does not move freely
- Parts detach at a later time
The first two scenarios are unlikely to cause an injury because they should be identified during preparation before the surgery. However, the third scenario could result in adverse events and revision surgery.
What is the problem?
The surgeon should hear a “click” when the components are assembled properly. If the surgeon implants a device that is not assembled properly, it could detach suddenly. This will probably occur within the first few weeks after the operation.
Recommendation for Patients
The patient will immediately experience pain, limited mobility, and loss of range-of-motion if the implant fails. Patients with a recalled hip implant should follow up with their orthopedic surgeon. Revision surgery is not recommended unless the patient is having problems with their implant.
What Products Were Recalled?
|Tandem Intl Bipolar 41od 22id||13LM12870|
|Tandem Intl Bipolar 41od 22id||14AM02714|
|Tandem Intl Bipolar 44od 28id||13LM17160|
|Tandem Intl Bipolar 44od 28id||13MM04139A|
|Tandem Intl Bipolar 45od 28id||13KM24097|
|Tandem Intl Bipolar 45od 28id||13LM04114|
|Tandem Intl Bipolar 45od 28id||13MM04143|
|Tandem Intl Bipolar 45od 28id||14AM00474|
|Tandem Intl Bipolar 45od 28id||14AM00478|
|Tandem Intl Bipolar 45od 28id||14AM02716|
|Tandem Intl Bipolar 45od 28id||14AM02717|
|Tandem Intl Bipolar 48od 28id||13MM13695|
|Tandem Intl Bipolar 48OD 28ID||14AM16531|
|Tandem Intl Bipolar 48OD 28ID||14BM14336|
|Tandem Intl Bipolar 49OD 28ID||13MM10141|
|Tandem Intl Bipolar 49OD 28ID||13MM10159|
|Tandem Intl Bipolar 49OD 28ID||14BM15206|
|Tandem Intl Bipolar 50OD 28ID||14AM00603|
|Tandem Intl Bipolar 51OD 28ID||14BM15248|
|Tandem Intl Bipolar 52OD 28ID||13LM07425|
|Tandem Intl Bipolar 52OD 28ID||13MM13698|
|Tandem Intl Bipolar 52OD 28ID||14AM02687|
|Tandem Intl Bipolar 53OD 28ID||13LM04213|
|Tandem Intl Bipolar 53OD 28ID||14AM21697|
|Tandem Intl Bipolar 54OD 28ID||14BM11528|
|Tandem Intl Bipolar 55OD 28ID||13KM22761A|
|Tandem Intl Bipolar 55OD 28ID||13KM22762|
Need a Hip Implant Lawyer in Texas?
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