Model Number N/A |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Failure of Implant (1924); Insufficient Information (4580)
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Event Date 11/22/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 02973.0001825034 - 2023 - 02992.D10: cat# 650-0661 lot# 314468 delta ceramic fem hd 36/0mm.Cat# 010000937 lot# 7144262 g7 hi-wall e1 liner 36mm g.Cat# 010000991 lot# 7414001 act artic e1 hip brg 22x36mm.G2: foreign: new zealand.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that the patient underwent an initial hip procedure.Subsequently, the patient was revised approximately 10 months later due to loosening of the acetabular components.The primary x ray reportedly showed that the cup was never seated properly.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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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.A review of the device history records identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: right total hip arthroplasty with likely loosening of the acetabular component and vertically oriented acetabular cup.A definitive root cause cannot be determined.The event is confirmed via medical reports of reviewed xray.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further information at the time of this report.
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Search Alerts/Recalls
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