ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 10 MM HEIGHT USE WITH TIBIA SIZES; PROSTHESIS, KNEE
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Model Number N/A |
Event Date 05/06/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant associated products : item#: 42502806202; femur trabecular metal cruciate retaining (cr); lot#:64065171.Item#: 42540000035; all poly patella cemented 35 mm diameter; lot#: 64441717.Item#: 42530007102; natural tibia trabecular metal two-peg porous fixed bearing right size e; lot#: 64405827.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is still implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 02729 , 0002648920 - 2020 - 00359.
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Event Description
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It was reported a patient had a right unilateral tka, and the patient experienced lysis of adhesions, limited rom, and pain and underwent a mua approximately six months later.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: no complication during the surgery.On (b)(6) 2020, patient underwent arthroscopy for arthrofibrosis and mua on (b)(6) 2020.On (b)(6) 2020, patient experienced pain, limited extension and flexion along with ambulating with antalgic gait.Scar tissue was overgrown patella button inferiorly and medially.Patient continue to experience stiffness.A definitive root cause cannot be determined.Per package insert, pain, poor range of motion are known adverse effect of the system.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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