MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT SM SIZE 4 PMA; OXFORD

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	01/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, that: it was reported that a patient underwent an initial right knee arthroplasty on an unknown date.Subsequently, the small right 4mm bearing was removed on (b)(6) 2022 as the metal x-ray marker came out of the bearing and was irritating the patient's soft tissues.Bearing was removed and replace with a new bearing of the same size.Patient involvement - revision.
Additional Manufacturer Narrative
(b)(4).Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it has been discarded by the user facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported, that: a patient underwent an initial right knee arthroplasty on an unknown date.Subsequently, the small right 4mm bearing was removed on jan 06, 2022, as the metal x-ray marker came out of the bearing and was irritating the patient's soft tissues.The bearing was removed and replaced with a new bearing of the same size.Patient involvement - revision.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: no product was returned; visual and dimensional evaluations could not be performed.The photograph and x-ray provided show that the x-ray marker is out of the bearing.A review of the device history record identified no related deviations or anomalies during manufacturing.This device is used for treatment.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.A review of complaint history found no additional related issues for this item and the reported part and lot combination.The photograph provided confirms that the x-ray marker is out of the bearing.Medical records have not been provided.No corrective/preventive actions are needed at this time.This complaint was determined not to be a new confirmed quality or manufacturing issue.Complaints are monitored through monthly complaint reviews in order to identify potential adverse trends.A warm tool is used to seal the wire in the bearing and without the product being returned we cannot check exactly what caused the wire to come out.Hence, a root cause cannot be determined.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 4 PMA
• Common Device Name: OXFORD
• 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: 13257698
• Report Number: 3002806535-2022-00010
• Device Sequence Number: 1463354
• Product Code: NRA
• UDI-Device Identifier: 05019279786152
• UDI-Public: 05019279786152
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

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: Health Professional
• Device Expiration Date: 02/03/2026
• Device Model Number: N/A
• Device Catalogue Number: 159569
• Device Lot Number: 571510
• 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: 01/06/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2021
• 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
• 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 Sex: Unknown