Model Number N/A |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Hematoma (1884); Necrosis (1971); Joint Dislocation (2374)
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Event Date 12/07/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: zimmer cat# 01.06010.306 avenir stem lat cemented 6 lot# 3039253 zimmer cat# 00500105200 shell 52 mm o.D.Lot# 64892224.Report source: foreign country: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2021-00461.
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Event Description
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It was reported that patient underwent a left hip arthroplasty.Subsequently, the patient was revised approximately 2.5 weeks later due to dislocation.It is believed that the original femoral component was cemented too proud.The patient hip joint was believed to be too tight.It was revised to a smaller size stem and placed with more anteversion.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.
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Event Description
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It was reported that patient underwent a left hip arthroplasty.Subsequently, the patient was revised approximately 2.5 weeks later due to recurrent dislocations.While attempting to reduce the hip, a significant abduction contracture was noted, and the patient dislocated again while in a knee immobilizer and using an abduction pillow.During the revision, a large hematoma and necrotic tissue was debrided, the posterior capsular repair was found ruptured, and the previous stem was found to have no anteversion and 3-4degrees of retroversion.A new stem was cemented into place with a new head.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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Upon reassessment of the reported event, the head was determined to be not reportable and did not contribute to the reported event.The initial report was forwarded in error and should be voided.
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Manufacturer Narrative
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Upon reassessment of the reported event, the head was determined to be not reportable and did not contribute to the reported event.The initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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