MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT SM SIZE 5 PMA; OXFORD HXLPE BEARINGS

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	02/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
15 feb 2022 it was reported, that: that a product with an expiration date of feb 13, 2022, was implanted on feb 15, 2022.The device was part of a consignment kit.It was discovered post-surgery that an expired product had been implanted.Patient outcome: unknown.Additional information received on 18 feb 2022.The device was part of a consignment kit.When was it discovered that an expired product had been implanted? (pre or post-surgery).- post-surgery.Please provide photographs of the stickers and the outer packaging, if available.- see attached the surgery report.
Additional Manufacturer Narrative
(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).The client has indicated that the product will not be returned to zimmer biomet for an investigation.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.Device remains implanted.
Event or Problem Description
It was reported, that: a product with an expiration date of feb 13, 2022, was implanted on (b)(6) 2022.The device was part of a consignment kit.It was discovered post-surgery that an expired product had been implanted.Patient outcome: unknown.Addi received on 18 feb 2022.1.The device was part of a consignment kit 2.When was it discovered that an expired product had been implanted? (pre or post-surgery).Post-surgery.3.Please provide photographs of the stickers and the outer packaging, if available.- see attached the surgery report addi received on 22 feb 2022.There was no extension or delay during or after this surgical procedure.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: a review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.A complaint history search is not required as the product is conforming to the specification.The device was used past the expiry date, this is a user error.This device is used for treatment.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.It has been confirmed that the instrument/implant is not within the scope or subject of any field actions or recalls which could be attributed to the reported event.The likely condition of the device when it left zimmer biomet is conforming to the specification.The product has not been returned for evaluation, the dhr review did not identify any issues.The root cause of the reported event cannot be determined with the information provided.No corrective or preventive action is required at this time.If any additional information is discovered or received that may adjust any conclusions or data, a supplemental report will be rendered accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OXF ANAT BRG RT SM SIZE 5 PMA
• Common Device Name: OXFORD HXLPE BEARINGS
• 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: 13576391
• Report Number: 3002806535-2022-00073
• Device Sequence Number: 4973868
• Product Code: NRA
• UDI-Device Identifier: 05019279786169
• UDI-Public: 05019279786169
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2022

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: 02/13/2022
• Device Model Number: N/A
• Device Catalogue Number: 159570
• Device Lot Number: 3972963
• 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: 02/15/2022
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2017
• 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