STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
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Model Number 1236-2-848 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/27/2020 |
Event Type
Injury
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Manufacturer Narrative
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An event regarding revision for unspecified reason involving an adm liner was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as no product was returned for evaluation.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there has been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information including the reason for revision surgery, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.The following devices were also listed in this report: cat# 6519-1-028; delta un.Fem hd 28mm r28 16/18; lot# 79305701; cat# 19-0005t; uni adaptor sleeve c taper ti; lot# 77912102.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Not returned to the manufacturer.
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Event Description
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It was reported through the submission of a usage sheet that the patient's left hip was revised.In comparing the usage sheets from the current and previous revision, a 28/48 mm 42e adm/ mdm poly insert, 28 mm universal taper head, and +5mm c-taper adapter sleeve were all swapped to the same devices of the same size.
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