STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 60MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Model Number 502-03-60F |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Pain (1994); Inadequate Osseointegration (2646)
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Event Date 12/21/2022 |
Event Type
Injury
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Event Description
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It was reported by the patient, that he was implanted with a right stryker hip on (b)(6) 2018.The patient alleges in or about (b)(6) 2018 he started to experience excruciating pain and couldn¿t put weight on his hip.The patient followed up with his primary surgeon and was diagnosed with bursitis.The patient continued to experience pain and stated he has seen multiple doctors.Allegedly in 2021 the patient went for a second opinion and the surgeon performed a radiolucency test and told the patient the acetabular cup was loose and revision surgery was recommended.The patient was revised (b)(6) 2021.The patient is seeking compensation for his pain and suffering.
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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.
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Event Description
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It was reported by the patient, that he was implanted with a right stryker hip on (b)(6), 2018.The patient alleges in or about (b)(6) 2018 he started to experience excruciating pain and couldn¿t put weight on his hip.The patient followed up with his primary surgeon and was diagnosed with bursitis.The patient continued to experience pain and stated he has seen multiple doctors.Allegedly in 2021 the patient went for a second opinion and the surgeon performed a radiolucency test and told the patient the acetabular cup was loose and revision surgery was recommended.The patient was revised (b)(6) 2021.The patient is seeking compensation for his pain and suffering.
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Manufacturer Narrative
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Reported event: an event regarding loosening involving trident shell was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned. clinician review: no medical records were received for review with a clinical consultant.Device history review: review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the root cause could not be determined because insufficient information was provided.Further information such as return of the device, pre- and post-operative x-rays, primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
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