ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) RIGHT 10 MM HEIGHT; 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
Muscular Rigidity (1968); Loss of Range of Motion (2032); Limited Mobility Of The Implanted Joint (2671)
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Event Date 12/10/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated report: 3007963827-2021-00022.Medical product: femur cemented cruciate retaining (cr) standard right size 5, item# 42502605802, lot# 64587123.Tibia cemented 5 degree stemmed right size c, item# 42532006402, lot# 63783332.Report source - (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that a patient underwent a right total knee arthroplasty and, subsequently, the patient underwent a manipulation under anesthesia due to stiffness.The stiffness was noted as resolved the same day without further complication.There is no additional information at this time.
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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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Manufacturer Narrative
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This follow-up is being submitted to relay additional information.No product was returned or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records and radiographs were provided and reviewed by a health care professional.Radiographs were not reviewed as images would not enhance the investigation process as adhesions and scar tissue are not visible via x-ray images.Review of the available records identified the following: initial surgery: pre op rom 12-130 degrees, no patellar resurfacing, no intra op complications noted, or time 63 minutes; (approximately two months¿ post implantation) stiff knee resulting in manipulation, resolved same day; three month follow-up: moderate pain, moderate difficulties, rom 30-100 degrees, some problems with activities, health score 69.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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