MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT SM SIZE 8 PMA; KNEE PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, that a product approximately 3 months past the expiry date was implanted.
Additional Manufacturer Narrative
(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).The product remains implanted in the patient.The investigation is in progress.Once the investigation has concluded, a follow-up mdr will be submitted.Remains implanted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.No product was returned as it was implanted and will not be revised.Visual inspection of the label in dhr shows an expiry date on product label as january 28th, 2022.The device history records for item # 159573 lot # 3964775 were reviewed for deviations and / or anomalies with no anomalies / deviations identified.Sterilisation certificate confirms that the process/product meets customer specifications and that zero non-conformities occurred during the irradiation run.The device is used for treatment.Medical records/radiographs were not provided.The likely condition of the device when it left zimmer biomet is conforming to specification.The reported event has not been confirmed as the product was not returned for evaluation and the dhr review did not identify any issues at final release of product from the manufacturing site.The definitive root cause of the reported event cannot be determined with the information provided, however user error is likely to have contributed to the reported event.An expired product letter by dr imran khan (research director) has been forwarded to complainant detailing theoretical risk of expired product against risk of revision.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 SM SIZE 8 PMA
• 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: 14217105
• Report Number: 3002806535-2022-00231
• Device Sequence Number: 11810841
• Product Code: NRA
• UDI-Device Identifier: 05019279786190
• UDI-Public: (01)05019279786190(17)220128(10)3964775
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 159573
• Device Lot Number: 3964775
• 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: 04/22/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2017
• 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
• Patient Sex: Unknown