STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRITANIUM ACETABULAR CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number UNK_JR |
Device Problem
Osseointegration Problem (3003)
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Patient Problems
Pain (1994); Injury (2348)
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Event Date 07/09/2018 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.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.Device not returned.
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Event Description
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It was reported through the filing of a lawsuit that allegedly the patient was implanted with a tritanium acetabular cup in her right hip on (b)(6) 2014 and in light of worsening symptoms she was taken back for revision surgery on (b)(6) 2018.It is further alleged "prior to surgery, it was discovered that, she had persistent pain in her right hip after the initial operation, and subsequent workup demonstrated loosening of the acetabular component.During that surgery, it was discovered that when the head was dislocated, fluid was seen.Moreover, the cup was loose and was removed without difficulty.The acetabulum was debrided of membranous material.".
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