MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT MD SIZE 3 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	Pain (1994)
Date of Event	01/10/2022
Type of Reportable Event	Serious Injury
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.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2022-00006, 3002806535-2022-00007.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device discarded.
Event or Problem Description
It was reported that there was a revision due to pain.
Event or Problem Description
It was reported, that: there was a revision due to an unknown reason.Oxford uni converted to total knee arthroplasty.Patient outcome: revision.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: the products were not returned for evaluation.Therefore, the investigation has been limited to the information provided, a review of the device history records, and a complaint history search.A review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.These devices are used for treatment.A review of complaint history identified additional 6 similar complaints about the reported item 159547 and no additional complaints about the reported item and lot combination, 20 similar complaints about the reported item 161469 and no additional complaints about the reported item and lot combination and 5 similar complaints about the reported item 154724 and no additional complaints about the reported item and lot combination.X-ray images are of poor quality ¿ images are not being sent to mmi at this time due to poor image quality.An mmi assessment would not enhance the investigation.The likely condition of the devices when they left zimmer biomet is conforming to the specification.The reported event has not been confirmed as the product has not been returned for evaluation and the dhr review did not identify any issues.The root cause of the reported event cannot be determined with the information provided.It has been confirmed that the implants are not within the scope or subject of any field actions or recalls which could be attributed to the reported event.Corrective or preventative action is not required.The root cause of the reported event cannot be determined with the information provided.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2022-00006-1, 3002806535-2022-00007-1.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 MD SIZE 3 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: 13248191
• Report Number: 3002806535-2022-00005
• Device Sequence Number: 19963533
• Product Code: NRA
• UDI-Device Identifier: 05019279785933
• UDI-Public: 05019279785933
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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
• Report Date (Section B): 05/04/2022

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: 06/27/2019
• Device Model Number: N/A
• Device Catalogue Number: 159547
• Device Lot Number: 517000
• 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: 01/10/2022
• Supplement Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2014
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 107 KG