MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT LG SIZE 3 PMA; KNEE PROTHESIS

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
T was reported that patient underwent revision due to lateral knee pain.Right knee total knee arthroplasty was performed during the operation.No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Concomitant medial products: unknown oxford single peg femur #item unknown #lot unknown.Unknown oxford tibial tray rm #item unknown #lot unknown.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record for item identified no deviations or anomalies during manufacturing related to the reported event.Device is used for treatment.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: here is advanced lateral compartment osteoarthritis.A joint effusion is noted.Bone quality is osteopenic.There is no evidence of joint overstuffing, but this would be best evaluated by earlier radiographs at the time of surgery.The current valgus alignment of the media unicompartmental arthroplasty could lead to lateral compartment stress and osteoarthritis.The root cause of the reported issue is attributed to disease progression.No corrective actions, preventive actions, or field actions resulted after investigation of this event.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2022-00466, 3002806535-2022-00468.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.

• Brand Name: OXF ANAT BRG RT LG SIZE 3 PMA
• Common Device Name: KNEE PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 15813098
• Report Number: 3002806535-2022-00467
• Device Sequence Number: 17474908
• Product Code: NRA
• UDI-Device Identifier: 05019279786282
• UDI-Public: (01)05019279786282(17)120711(10)1332637
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/11/2012
• Device Model Number: N/A
• Device Catalogue Number: 159582
• Device Lot Number: 1332637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2007
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male