ZIMMER SWITZERLAND MANUFACTURING GMBH COCR HEAD 28/-4 S 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Model Number N/A |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Failure of Implant (1924)
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Event Date 05/14/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10: item#61272842; lot#3146967; bipolar insert, modular, 42/28.Item#4710500394-3; lot#ax44ch0111; optipac 40 refob bone cmt r-3.Item#0106010003; lot#3123522; avenir muller, stem, standard, uncemented, ha, 3, taper 12/14.Item#61270044; lot#3145111; bipolar shell, modular, 44.G2- germany.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0009613350 - 2023 - 00324.
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Event Description
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It was reported that patient underwent implantation with hip prostheses.Postoperatively, during the exercise, a decoupling of head and inlay occurred with dislocation of the hip.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).Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00324-1.This follow-up report is being submitted to relay additional and/or corrected information.The devices have not been returned for examination due to missing patient consent.Therefore, no device examination could be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.In total three undated radiographs were provide, consisting of one ap pelvis and two ap views of the right hip, were received and evaluated by a health care professional (radiologist).The assessment identified a dislocation of the right hip arthroplasty with displacement of the acetabular implant.The prosthetic femoral head is seated within the native acetabular fossa.There is no fracture.The bone quality appears osteopenic.With the available information, the reported dislocation can be confirmed; nevertheless, 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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It was reported that patient underwent implantation with hip prostheses.Postoperatively, during the exercise, a decoupling of head and inlay occurred with dislocation of the hip.This resulted in revision surgery being performed six (6) days after the initial procedure.Attempts have been made and no further information has been provided.
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