MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PKS ANATOMIC ARCOM MENISCAL BRG - SMALL LEFT SIZE 3; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994)
Date of Event	05/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: unknown oxford femoral component; catalog# unknown; lot# unknown.Unknown oxford tibial component; catalog# unknown; lot# unknown.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: 3002806535-2022-00245, 3002806535-2022-00246.
Event or Problem Description
It was reported that the patient underwent a revision surgery approximately 8 months after the implantation due to pain and metal allergy.Additional information requested.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.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.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information at time of this report.Due diligence has been completed and no additional information has been made available.
Additional Manufacturer Narrative
This follow up report is being submitted to relay additional information.The following sections have been updated: b4; b5; d10; g3; h2; h3; h6; h10.D10: medical product: oxf twin-peg cmntd fem sm pma: catalog#161468, lot#681550; oxf uni tib tray sza lm: catalog#154718, lot#681800.Visual examination of the returned product found it to exhibit wear marks.Device history record was reviewed and no discrepancies related to the reported event were found.The likely condition of the device when it left zimmer biomet is conforming to specification.Root cause was unable to be determined.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: OXFORD PKS ANATOMIC ARCOM MENISCAL BRG - SMALL LEFT SIZE 3
• Common Device Name: PROSTHESIS, KNEE
• 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: 14539613
• Report Number: 3002806535-2022-00247
• Device Sequence Number: 5157146
• Product Code: NRA
• UDI-Device Identifier: 05019279785865
• UDI-Public: (01)05019279785865(17)240720(10)335150
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2022
• 2 Devices were Involved in the Event: 1 2

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: 07/20/2024
• Device Model Number: N/A
• Device Catalogue Number: 159540
• Device Lot Number: 335150
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/17/2022
• 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: 05/02/2022
• Supplement Date Received by Manufacturer: 06/01/2022; 06/30/2022
• Initial Report FDA Received Date: 05/30/2022
• Supplement Report FDA Received Date: 06/09/2022; 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2019
• 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; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female