Model Number 1517-60-112 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Muscle/Tendon Damage (4532); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/18/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that the patient had a dfr done on (b)(6) 2020.She ruptured her quadriceps tendon in (b)(6) 2020 and now had an infection.The insert, poly button and hinge pin were removed.The joint was washed and scrubbed then a new insert, poly button and hinge pin were implanted.No surgical delay noted.Doi: (b)(6) 2020, dor: (b)(6) 2021, right knee.
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Event Description
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Additional information was received stating that there were no implants revised at the time of the extensor mechanism repair.The patella has an implant on it.The implant is not a depuy implant and it was not revised.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Removed clinical symptoms code tendon injury.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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