Model Number 5980-37-02 |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Synovitis (2094); Arthralgia (2355); Inadequate Pain Relief (2388); Ambulation Difficulties (2544)
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Event Date 08/22/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Medical product: articular surface size ef 12 mm height use with plate 3: catalog#00596403212, lot#63908007; femoral component option for cemented use only size e: catalog#00599601502, lot#63931769; optipac 60 refob bone cmt r-3: catalog#4711500396-3, lot#729aa03415.Report source: foreign: (b)(6).Multiple mdr reports have been filed for this event.Please see associated report: 0001822565-2023-00065.The product will not be returned to zimmer biomet for evaluation as the product remains implanted.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.
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Event Description
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It was reported via patient's legal counsel that a patient underwent an initial right total knee arthroplasty.Since implantation the patient has experienced continuous pain and difficulty with mobility.Continuation of prescription pain medication did not relieve the patient's symptoms.Approximately four years post implantation, xray images revealed loosening of the medial tibial plateau and a diagnostic arthroscopy found synovitis from polyethylene abrasion deposits in the joint.Cultures and tissue samples showed no evidence of infection.The patient is scheduled for an upcoming revision surgery due to aseptic loosening and polyethylene bearing wear.It was reported that no further information is available.
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Event Description
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No further event information at time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned and pictures provided were insufficient to complete visual and dimensional evaluations.The product remains implanted.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: no patellar resurfacing/implant, discharge report states procedure and post-op stay went well without complications, post-op x-ray shows implants in correction position and alignment, and the patient was able to increase range of motion with rehab discharge.Additionally, patient made good progress with physical therapy.Root cause was unable to be determined.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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Search Alerts/Recalls
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