ZIMMER BIOMET, INC. NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING; PROSTHESIS, KNEE
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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
Pain (1994); Swelling (2091); Limited Mobility Of The Implanted Joint (2671); Patient Problem/Medical Problem (2688)
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Event Date 07/10/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: therapy date: unknown.42502006402 femur cemented cruciate retaining (cr) 63945498; 42522100812 articular surface medial congruent 64119057; 42540000035 all poly patella cemented 35 mm diameter 64214480.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains 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: 3007963827-2020-00136, 3007963827-2020-00137, 0002648920-2020-00253.
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Event Description
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It was reported that a patient underwent an initial right total knee arthroplasty.Subsequently, the patient reported continued difficulty with activity of daily living, ambulating, swelling, and stiffness over time.The patient remains dissatisfied but has received no further treatment/intervention.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g4; g7; h1; h2; h3; h6.Medical records/radiographs were evaluated and the reported event was not confirmed.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record (dhr) was reviewed and no discrepancies were found.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following no intra-op complication noted.During the 1 year follow up visits, the patient experienced moderate pain, limping, difficulty with daily activities, stiffness, and swelling.No further action was taken.A definitive root cause cannot be determined.Per package insert, persona the personalized knee solution: swelling, pain, limited rom are known adverse effects of this procedure.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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Search Alerts/Recalls
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