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

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 10/20/2021

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, as it has been discarded.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00468 and 3002806535-2021-00470.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) 2015 at (b)(6) hospital.Subsequently, a revision procedure due to unknown reason was performed on (b)(6) 2021 by dr.(b)(6) at (b)(6) hospital.

Event Description

Sit was reported that a patient underwent an initial right knee arthroplasty on (b)(6), 2015 at (b)(6) hospital.Subsequently, a revision procedure due to unknown reason was performed on (b)(6), 2021 by dr.(b)(6) at (b)(6) hospital.

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.A review of the complaints database for 3 years prior to the notification date has found the following: 3 similar reported complaints for item (b)(4) (including initiating complaint).17 similar reported complaints for item (b)(4) (including initiating complaint).5 similar reported complaints for item (b)(4) (including initiating complaint).There were no additional complaints against any of the 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 specification.The root cause of the reported event cannot be determined with the information provided no corrective action required at this time as the root cause of the reported event has not been determined.These part and lot combinations are not associated with any recalls as of current date.Capa: no corrective or preventive action required at this time.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00468-1.3002806535-2021-00470-1.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.H3 other text : device discarded.

• 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: 12726649
• MDR Text Key: 279256433
• Report Number: 3002806535-2021-00469
• 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: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• 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: 276770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2015
• 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: 73 YR
• Patient Sex: Male