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
Inflammation (1932); Pain (1994); Injury (2348); Reaction (2414); Inadequate Osseointegration (2646)
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Event Date 02/12/2018 |
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.
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Event Description
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It was reported through the filing of a lawsuit that allegedly on (b)(6) 2010 the patient's left hip was implanted with an tritanium acetabular cup.It is further alleged that she began experiencing discomfort with complaints of extreme pain with unclear etiology, despite diagnostic workup.She was taken back for revision surgery on (b)(6) 2018 and it is alleged that at revision "minimal fixation of the tritanium component was identified" and the tritanium cup was removed with "minimal difficulty" and "minimal bone loss".It is further alleged that "in addition to her loose cup, moderate taper corrosion was identified.".
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