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

Model Number N/A

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

Patient Problem Pain (1994)

Event Date 10/27/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Concomitant medical products: 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: 3002806535-2021-00481 and 3002806535-2021-00483.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty on (b)(6) 2015.Subsequently, a revision procedure due to pain was performed on (b)(6) 2021.

Event Description

It was reported, that: a patient underwent an initial right knee arthroplasty on (b)(6) 2015.Subsequently, a revision procedure due to pain was performed on (b)(6) 2021.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: the product has not been returned for evaluation.X-rays have been provided.The implants were in situ for approximately 6 years.The investigation has been limited to the information provided, an x-ray review, a review of the device history records, and a complaint history search.The observed gaps and/or radiolucent lines may be indicative of sub-optimal cementing technique and/or component placement in this instance, which may have contributed to the reported patient¿s pain.Other contributing factors cannot be discussed without examination of the revised components and without the provision of relevant surgical notes and additional radiographic and patient information.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 was assessed for three years prior to the notification date and identified 6 similar complaints about item 159575 including the initiating complaint.There were no additional complaints against the lot 562150.16 similar complaints about item 161469 including the initiating complaint.There were no additional complaints against lot 781010.4 similar complaints about item 154721 including the initiating complaint.There were no additional complaints against lot 705420.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 left by zimmer biomet is conforming to the specification.The root cause of the reported event can not be determined with the information provided the investigation is completed based on currently available information.If any additional information becomes available, then the complaint will be reopened and further investigated.No corrective or preventive action is required at this time.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2021-00483-1, 3002806535-2021-00481-1.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 TWIN-PEG CMNTD FEM MD 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: 12745161
• MDR Text Key: 279831349
• Report Number: 3002806535-2021-00482
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279438242
• UDI-Public: 05019279438242
• 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
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• 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: 161469
• Device Lot Number: 781010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2014
• 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: 58 YR