MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM XL PMA; OXFORD CEMENTED FEMORALS

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	11/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) initial report.Concomitant medical products: 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: 3002806535-2021-00487, 3002806535-2021-00489.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 (b)(6) 2018.Subsequently, a total knee revision procedure due to unknown reason was performed on (b)(6) 2021.
Event or Problem Description
It was reported that a patient underwent an initial right knee arthroplasty on (b)(6), 2018.Subsequently, a total knee revision procedure due to lateral wear was performed on (b)(6), 2021.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The reason for revision is lateral wear.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00487-1, 3002806535-2021-00489-1.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Complaint summary: 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.Review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.Dhr item 154776 lot 669130, dhr item 159589 lot 294070 & dhr item 161471 lot 00380 confirms conformance to specification on final release.From the limited information provided the most likely cause could not be determined.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Review of complaint history database for 3 years prior to the notification date has found no similar complaints for item #161471 and item #159589.The search identified (3) similar reported complaints for item #154776 (including initiating complaint).There were (0) additional complaints against the lot #669130.These devices are used for treatment.The implants used have been confirmed to be 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 specification.The root cause of the reported event is likely to be disease progression, which is not considered device related.No corrective action required at this time as the root cause of the reported event is not device related multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00487-2, 3002806535-2021-00489-2.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that a patient underwent an initial right knee arthroplasty on (b)(6) 2018.Subsequently, a total knee revision procedure due to lateral wear was performed on (b)(6), 2021.

• Brand Name: OXF TWIN-PEG CMNTD FEM XL PMA
• Common Device Name: OXFORD CEMENTED FEMORALS
• 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: 12778718
• Report Number: 3002806535-2021-00488
• Device Sequence Number: 14958872
• Product Code: NRA
• UDI-Device Identifier: 05019279438266
• UDI-Public: 05019279438266
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• 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,Followup
• Report Date (Section B): 12/10/2021

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 Model Number: N/A
• Device Catalogue Number: 161471
• Device Lot Number: 070380
• 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: 11/03/2021
• Supplement Date Received by Manufacturer: 11/15/2021; 12/09/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 11/16/2021; 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2018
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 100 KG