MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT LG SIZE 4 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	Failure of Implant (1924)
Date of Event	02/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial report.The client has indicated that the product will not be returned to zimmer biomet for an investigation.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2022-00056, 3002806535-2022-00057.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.
Event or Problem Description
It was reported, that: a patient underwent an initial left knee arthroplasty on (b)(6) 2021.Subsequently, a revision procedure due to unknown reasons was performed on (b)(6) 2022.Patient outcome: revision.No delay.
Event or Problem Description
It was reported, that: a patient underwent an initial left knee arthroplasty on (b)(6) 2021.Subsequently, a revision procedure due to unknown reasons was performed on (b)(6) 2022.Patient outcome: revision.No delay.Addi 09 feb 2022.No further information is available.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: the product has not been returned for evaluation, and x-rays or medical notes have not been provided.Therefore, the investigation has been limited to the information provided, a review of the device history records, and a complaint history search.The device history records for part # 154755 and lot # 333460 were reviewed for deviations and/ or anomalies with the following deviations/anomalies identified: a non-conformance was written for sample p1-g1 was found with a double tyvek causing a visual and adhesive failure with 8 pieces affected.Orders were reworked.A review of the complaints database for 3 years before the notification date has identified the following information: three (3) similar complaints about item #159555 (including the initiating complaint).No additional search against the lot number was required as this complaint was the only record of a revision due to unknown reasons against the item number.Three (3) similar complaints about item #161470 (including the initiating complaint).No additional search against the lot number was required as this complaint was the only record of a revision due to unknown reasons against the item number.Two (2) similar complaints about item #154775 (including the initiating complaint).There were zero (0) additional complaints against lot #333460.These devices are used for treatment.Not enough information has been provided to determine if all implants are compatible.These part and lot combinations are not associated with any recalls at the time the search was conducted.The likely condition of the devices when they left zimmer biomet is conforming to the specification.The root cause of the reported event can not be determined with the information provided.No corrective action is required at this time as the root cause of the reported event has not been determined.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2022-00056-1, 3002806535-2022-00057-1.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 LT LG SIZE 4 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: 13497090
• Report Number: 3002806535-2022-00055
• Device Sequence Number: 4296020
• Product Code: NRA
• UDI-Device Identifier: 05019279786015
• UDI-Public: 05019279786015
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2022

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: 05/20/2026
• Device Model Number: N/A
• Device Catalogue Number: 159555
• Device Lot Number: 571480
• 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: 02/02/2022
• Supplement Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2021
• 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
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Male