Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Hematoma (1884); Unequal Limb Length (4534)
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Event Date 01/10/1996 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10 ¿ unknown ms-30 stem; item# unknown; lot# unknown.Unknown sl shell; item# unknown; lot# unknown.#1 unknown screw; item# unknown; lot# unknown.#2 unknown screw; item# unknown; lot# unknown.#3 unknown screw; item# unknown; lot# unknown.Unknown cement; item# unknown; lot# unknown.G2 ¿ foreign ¿ switzerland.H10 ¿ h3 ¿ other: device evaluation could not be performed as part# and lot# unknown.Also, device location is unknown.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Event Description
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It was reported that an initial left total hip arthroplasty was performed approximately twenty-seven and a half years ago.Subsequently, the patient had considerable excess leg length on the operative side and required revision.The patient underwent a revision of the femoral head with hematoma evacuation and lysis of adhesions thirty-five days after the initial surgery.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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Manufacturer Narrative
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(b)(4).H10: h3: other: device evaluation could not be performed as part# and lot# unknown.Also, device location is unknown.This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of manufacturing records cannot be performed without product identification.Device is used for treatment.Medical documents in the form of surgical reports were provided which detail the reported event.Based on the available information, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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