ENCORE MEDICAL L.P EMPOWR PS KNEETM TIBIAL INSERT, SIZE 5, 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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Catalog Number 343-10-705 |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
Joint Laxity (4526)
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Event Date 03/25/2024 |
Event Type
Injury
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Event Description
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Revision surgery: due to doctor resurfaced pt's patella and upsized poly.
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Manufacturer Narrative
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The reason for this revision surgery, the agent reported "(doctor resurfaced patient's patella and upsized poly)".The actual length of in-vivo for the item listed is unknown as the original surgery date was not provided or could be established.This investigation is limited in scope as only partial information was provided to djo surgical - austin for review.The revised item was not returned for examination and the item and or lot number was not provided.To adequately investigate this event, the part and lot number are necessary.If this information is submitted at a future date, this investigation will be re-evaluated.Customer complaint history of the reported item showed no present trends or on-going issues that are needing a review.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.The surgeon performed this revision to remedy the patient's condition.This complaint will be closed pending receipt of additional information.No further action is deemed necessary at this time.
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