ZIMMER GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14; PROSTHESIS, HIP
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Model Number N/A |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Scar Tissue (2060); Joint Dislocation (2374); Muscle/Tendon Damage (4532)
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Event Date 01/26/2024 |
Event Type
Injury
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Event Description
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It was reported that a patient had an initial right total hip arthroplasty performed approximately one year ago.Subsequently, the patient was revised due to recurrent dislocations.During the revision, it was noted that the patient¿s initial capsular repair was completely torn on the posterior capsule which had scarred down posteriorly causing dislocations.The scar tissue was removed which increased stable range of motion.The head, neck, and liner were replaced with a constrained system which further enhanced stable range of motion.The initial cup and stem were left intact, and the procedure was completed without complications.Diligence is complete and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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(b)(4).D10.Liner standard 3.5 mm offset 36 mm i.D.For use with 58 mm o.D.Shell item# 00630505836 lot#64970915.Modular neck c 12/14 neck taper use with +0 heads only item#00784803300 lot#65603456.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.
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Manufacturer Narrative
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No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Review of the complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.Complaints are monitored per complaint trending process in order to identify potential adverse trends.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed.Followed by a revision was performed due to recurrent dislocations.During the revision it was noted there was a tear of the capsular repair and a large amount of scar tissue.The head, liner, and neck were revised with no complications noted.Op note report presence of a capsular tear.With the available information, it cannot be established if this issue is a consequence of the multiple dislocations or, instead, a contributing factor leading to the reported event.A definitive root cause cannot be determined.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 additional event information.
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Search Alerts/Recalls
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