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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/03/2021

Event Type  Injury  

Event Description

It was reported that: a patient underwent an initial right knee arthroplasty on (b)(6) 2016.Following this, a revision procedure due to unknown reason was performed on (b)(6) 2021.

Manufacturer Narrative

(b)(4).Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00523, , 3002806535-2021-00524.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not being returned to zb.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reason for revision - lateral wear and pain.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2021-00523-1, 3002806535-2021-00524-1.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty on (b)(6) 2016.Subsequently, a revision procedure due to unknown reason was performed on (b)(6) 2021.Patient outcome: revision.: reason for the revision.Lateral wear and pain.Operative notes, both initial and revision (as applicable)? all the pre notes were sent.Name of the surgeon who performed the initial procedure? same doctor.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: the product has not been returned for evaluation, 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.X-rays have been provided.However, as the event reports disease progression which is not device-related, an x-ray review is not required.A review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.A review of complaint history identified additional similar complaints about the reported item numbers and no additional complaints about the reported item and lot combinations.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 the specification.The root cause of the reported event is disease progression, which is not considered device-related.The investigation is completed based on currently available information.If any additional information becomes available, then the complaint will be reopened and further investigated.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2021-00523-2; 3002806535-2021-00524-2.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.

Event Description

It was reported, that: a patient underwent an initial right knee arthroplasty on (b)(6) 2016.Subsequently, a revision procedure due to unknown reasons was performed on (b)(6) 2021.Patient outcome: revision.

• Brand Name: OXF TWIN-PEG CMNTD FEM SM PMA
• Type of Device: 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: 12968032
• MDR Text Key: 281990278
• Report Number: 3002806535-2021-00525
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279438228
• UDI-Public: (01)05019279438228(17)250325(10)537260
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 161468
• Device Lot Number: 537260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 102 KG