STRYKER ORTHOPAEDICS-MAHWAH MODULAR DUAL MOBILITY INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
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Catalog Number 626-00-38D |
Device Problem
Osseointegration Problem (3003)
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Patient Problems
Pain (1994); Discomfort (2330); Injury (2348); Inadequate Osseointegration (2646)
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Event Date 05/24/2019 |
Event Type
Injury
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Manufacturer Narrative
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The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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It was reported that allegedly the patient was implanted with a tritanium acetabular cup in her right hip on (b)(6) 2016 and began experiencing pain and discomfort.It is further alleged diagnostic workup revealed device loosening and in light of worsening symptoms she was taken back for revision surgery to her right hip on (b)(6) 2019.Allegedly "during surgery, micromotion of the cup was observed.The revision surgeon noted blackish discoloration at the interface between acetabular cup and liner.The acetabular cup was noted to have been primarily adhered by fibrous tissue".
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Search Alerts/Recalls
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