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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Loss of Range of Motion (2032); Scar Tissue (2060); Swelling/ Edema (4577)
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Event Date 01/27/2021 |
Event Type
Injury
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Event Description
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It was reported a patient had an initial right total knee arthroplasty followed by a manipulation under anesthesia and revision one year eleven months post implantation due to aseptic failure.Subsequently, the patient underwent a second manipulation under anesthesia two months later due to swelling, limited range of motion, stiffness, adhesions, and scar tissue.All implants remain in place.
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products(reported) ------------------------------------------- 42522601010 persona articular surface fixed bearing (cps) rt 10mm lot# 63738909 additional associated products(not reported) ------------------------------------------- 42540000041 all poly patella cemented 41 mm di lot# 64825538 42556807005 femoral posterior augment cemented size 11, 11+ 5mm lot# 64485582 42545001011 femoral central cone size small lot# 64627878 42556607005 femoral distal augment cemented size 11, 11+ 5mm lot# 64363695 42556607005 femoral distal augment cemented size 11, 11+ 5mm lot# 64661433 42556807005 femoral posterior augment cemented size 11, 11+ 5mm lot# 64661624 42560113520 stem ext straight splined uncemented 20mm dia +135mm l lot# 64567557 42545000513 tibial central cone size large lot# 64643019 42542007902 tibia fixed cemented right size g lot# 64507531 42560317514 stem ext 3mm offset splined uncemented 14mm dia +175mm l lot# 64642454 5036963 palacos cement lot# 94934912 5036963 palacos cement lot# 94434814 5036963 palacos cement lot# 93904859.
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Search Alerts/Recalls
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