ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD LEFT SIZE 7; PROSTHESIS, KNEE
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Model Number 42-5026-062-01 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273); Patient Device Interaction Problem (4001)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)
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Event Date 12/24/2019 |
Event Type
Injury
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Event Description
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It was reported that a patient underwent an initial left total knee arthroplasty without complications.Subsequently, the patient has reported ongoing pain, swelling, and popping in the knee for the past two years and four months since implantation.Additionally, the patient is having range of motion issues with one knee and cannot bend or kneel.The patient has had bilateral knee replacements and it is unknown which knee is having range of motion complications.No medical intervention has been reported at the time of this report.It was reported that no further information is available.
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Manufacturer Narrative
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(b)(4).Medical products: natural tibia cemented 5 degree stemmed left size e: catalog#42532007101, lot#64417330; articular surface fixed bearing ultracongruent (uc) left 14 mm height: catalog#42512200514, lot#64279930; all-poly patella cemented 32 mm diameter: catalog#42540200032, lot#64540883; refobacin bc r 1x40 us: catalog#110034355, lot#818eak2709, qty#2.Multiple mdr reports have been filed for this event.Please see associated reports: 3007963827-2022-00137; 3007963827-2022-00138; 0002648920-2022-00124.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.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections have been updated: b2; b4; b5; g3; h2; h3; h6; h10.H6: proposed component (annex g) code is mechanical (g04) - femur.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.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 no complication during the initial surgery.No further records were provided for ongoing reported issue.Root cause was unable to be determined.Per package insert, pain, poor range of motion, and swelling are known adverse effects 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 at time of this report.
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