STRYKER ORTHOPAEDICS-MAHWAH CUP IMPACTOR BOLT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Model Number 1440-2011 |
Device Problems
Device Difficult to Setup or Prepare (1487); Difficult to Remove (1528)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/06/2022 |
Event Type
malfunction
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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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Primary procedure, left hip.It was reported that after the cup was inserted, the magnetic bolt was cold welded to the impactor and could not be removed at the back table.Surgery was completed successfully with no delay.Rep reported that replacement is needed, and confirmed that no further information will be released by the hospital or surgeon.
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Event Description
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Primary procedure, left hip.It was reported that after the cup was inserted, the magnetic bolt was cold welded to the impactor and could not be removed at the back table.Surgery was completed successfully with no delay.Rep reported that replacement is needed, and confirmed that no further information will be released by the hospital or surgeon.
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Manufacturer Narrative
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Reported event an event regarding disassembly issue involving a da instrument bolt was reported.The event was confirmed via evaluation of the returned device.Method & results -product evaluation and results: visual inspection of the returned devices indicated that the impactor and the bolt could not be disassembled by hand or with tools.Scratches observed on surface consistent with in-service use.The reported event is confirmed.-clinician review: no medical records were received for review with a clinical consultant.-device history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusion: visual inspection of the returned devices indicated that the impactor and the bolt could not be disassembled by hand or with tools.Scratches observed on surface consistent with in-service use.The reported event is confirmed.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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