Model Number N/A |
Device Problem
Use of Device Problem (1670)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/11/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 42500606202 - femur cemented posterior stabilized (ps) standard right size 7 - 65174010.42532007102 - tibia cemented 5 degree stemmed right size e - 65425233.00597206529 - all poly petella standard cemented size 29 mm diameter 8.0 mm thickness - 65270006.3003940001-3 - refobacin bone cement r 1x40-3 - y25caf1002.Report source: foreign country : thailand.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 knee surgery and the following day, the report of what products were used in the case was reviewed and it was identified that an articular surface of a mismatched size was used in this case.The packaging of the implant was correct.The patient had not experienced any complications postop, however, the surgeon decided that this mismatch would cause risks of instability and dislocation and that the patient should undergo a revision surgery to replace the articular surface with the correct size.The patient underwent a revision surgery one day later.There was no surgical delay.The surgical technique was utilized.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.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.The root cause of the reported issue is attributed to user not following the instruction provided in the ifu which leads to user using incompatible implants.The ifu provided the compatible table.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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