Model Number 1518-20-038 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Injury (2348); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.(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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Knee claim letter received.Claim letter alleged that patient sustained personal injury as a result of implantation of a defective depuy attune knee device.Doi: (b)(6) 2016, dor: unk unknown knee.Medical records reviewed: patient underwent a right knee tka utilizing attune implants with unknown cement for osteoarthritis on (b)(6) 2016.Surgeon indicates some type of reconstruction for possible fracture or acl injury was performed prior to the tka.No further details provided.Office notes on 13-jun-2018 indicate the patient has undergone a closed manipulation under anesthesia for residual stiffness on an unknown date.
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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.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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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Search Alerts/Recalls
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