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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); Burning Sensation (2146); Ambulation Difficulties (2544); Increased Sensitivity (4538); Swelling/ Edema (4577)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event: 3007963827-2023-00018, 3007963827-2023-00019, and 3007963827-2023-00020.Medical products: articular surface fixed bearing (ps) left 12 mm height, item#: 42512400412, lot#: 64163707; femur cemented (ps) narrow left size 4, item#: 42500005601, lot#: 63903850; tibia cemented 5 degree stemmed left size c, item#: 42532006401, lot#: 64520896; biomet bc r 1x40 us, item#: 110035368, lot#: 913cal1802.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 patient has developed complex regional pain syndrome experiencing pain, swelling, difficulties with rom, and hypersensitivity approximately two years post implantation attempts to obtain additional information have been made; however, no more information is available.
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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 were provided and reviewed by a health care professional.Review of the available records identified the following: from office visit: ambulates only short distances, with walker- no walker used prior to surgery; discouraged by rom gained, rom 10-88; taking tylenol as needed for pain.From subsequent office visit: left knee pain and swelling, hypersensitivity from knee all the way down to her foot really since surgery, warmth but no fevers/chills/or other signs; rom 90-95.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: anatomic alignment of the post-operative left knee arthroplasty.Left knee arthroplasty components are anatomically aligned and there is no acute abnormality.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 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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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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