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Catalog Number 42540200035 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
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Patient Problems
Pain (1994); Swelling/ Edema (4577)
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Event Date 03/15/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Medical product: femur cemented posterior stabilized (ps) standard right size 6: catalog#42500606002, lot#63731034; tibia cemented 5 degree stemmed right size f: catalog#42532007502, lot#63744241; articular surface fixed bearing posterior stabilized (ps) right 13 mm height : catalog#42522400713, lot#62732820; palacos rg 1x40 single: catalog#00111314001, lot#86694600.Multiple mdr reports have been filed for this event.Please see associated reports: 3007963827-2022-00139; 3007963827-2022-00140; 0001822565-2022-01444; 0001822565-2022-01446.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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Event Description
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It was reported that a patient underwent an initial right total knee arthroplasty without complications.Subsequently, the patient has reported ongoing pain, swelling, and popping in the knee for the past four years and two 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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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.The following sections have been updated: b1; b4; b5; g3; h2; h6; h10.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Medical records were provided and reviewed by a health care professional.Review of the available records identified no complications during the initial surgery.No further records were provided for the ongoing reported issue.Root cause was unable to be determined.Per package insert of products, 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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Search Alerts/Recalls
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