MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PKS ANATOMIC ARCOM MENISCAL BEARING MEDIUM LEFT SIZE 3; KNEE PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial left knee arthroplasty and approximately two (2) years post-implantation is still experiencing pain and instability.Due diligence is in progress for this complaint; to date no additional information has been received.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: oxf uni cmntls tib sz c lm item#166574 lot#3922603, oxford uni twin-peg femoral md item#166942 lot#j6466714, palacos r+g 2x40g item #66017569 lot #92804884.Report source: (b)(6).Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2022 ¿ 00287, 3002806535 - 2022 ¿ 00288.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
No product was returned or pictures provided; visual and dimensional evaluations could not be performed to confirm reported event.Review of the device history record (mhr item# 159547 lot# 6483393) identified no deviations or anomalies during manufacturing.Devices are used for treatment.Medical records were not provided.A definitive root cause cannot be determined.

• Brand Name: OXFORD PKS ANATOMIC ARCOM MENISCAL BEARING MEDIUM LEFT SIZE 3
• Common Device Name: KNEE PROSTHESIS
• 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: 14849593
• Report Number: 3002806535-2022-00286
• Device Sequence Number: 2350797
• Product Code: NRA
• UDI-Device Identifier: 05019279785933
• UDI-Public: (01)05019279785933(17)240207(10)6483393
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/07/2024
• Device Model Number: N/A
• Device Catalogue Number: 159547
• Device Lot Number: 6483393
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2022
• Supplement Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 66 KG