STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
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Model Number 1236-2-848 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Joint Dislocation (2374); Ambulation Difficulties (2544)
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Event Date 10/16/2020 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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The initial tha was performed in 2018, the installation angle of the cup was very good but mdm dislocation was diagnosed.Initially, it was expected that the patient's pelvic tilt would progress which caused dislocation, but the head and polyethylene had already dissected in the body already.Since the color of the head has changed, the metal liner and polyethylene were not moved smoothly, and it was thought that the head and cup may have been impinged and dislocated.The polyethylene has already damaged it when it was removed, there is scratches now and the slip is not very good.After putting the head in polyethylene, the sr is planned to check if it turns smoothly.The sliding surface between the metal liner and polyethylene cannot be confirmed, but it is suspected that this was the cause.
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Event Description
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The initial tha was performed in 2018, the installation angle of the cup was very good but mdm dislocation was diagnosed.Initially, it was expected that the patient's pelvic tilt would progress which caused dislocation, but the head and polyethylene had already dissected in the body already.Since the color of the head has changed, the metal liner and polyethylene were not moved smoothly, and it was thought that the head and cup may have been impinged and dislocated.The polyethylene has already damaged it when it was removed, there is scratches now and the slip is not very good.After putting the head in polyethylene, the sr is planned to check if it turns smoothly.The sliding surface between the metal liner and polyethylene cannot be confirmed, but it is suspected that this was the cause.
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Manufacturer Narrative
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Reported event: an event regarding dislocation involving an adm liner was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection of the returned device indicates that explantation damages as well as surface scratches were observed.Clinician review: no medical records were received for review with a clinical consultant.Device history review: device history 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 exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes and x-rays are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
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