MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT MD SIZE 4 PMA; OXFORD HXLPE BEARINGS

Model Number N/A

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

Patient Problems Joint Dislocation (2374); Insufficient Information (4580)

Event Date 10/21/2021

Event Type  Injury  

Event Description

It was reported that a patient underwent an initial right knee arthroplasty on (b)(6) 2020.Subsequently, a revision procedure due to unknown reason was performed on (b)(6) 2021.

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.Associated products: medical product: oxf twin-peg cmntd fem md pma; catalog no.: 161469; lot no.: 805290.Medical product: oxf uni tib tray sz c rm pma; catalog no.: 154723; lot no.: 197420.Medical product: biomet bc r 1x40 us; catalog no.: 110035368; lot no.: 005eae2407.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device discarded.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty on (b)(6) 2020.Subsequently, a revision procedure due to bearing dislocation was performed on (b)(6) 2021.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Additional information received: reason for revision: dislocation.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) 2020.Subsequently, a revision procedure due to bearing dislocation was performed on (b)(6) 2021.

Manufacturer Narrative

This final report is being submitted to relay additional information.Complaint summary: product has not been returned for evaluation.X-rays or medical notes have not been provided.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 identified the following information: seven (7) similar complaints for item #159576 (including the initiating complaint).There were zero (0) additional complaints against the lot #878490.This device is used for treatment.The implant 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 device when it 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.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: item discarded.

• Brand Name: OXF ANAT BRG RT MD SIZE 4 PMA
• Type of Device: 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: 12818340
• MDR Text Key: 280807786
• Report Number: 3002806535-2021-00497
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279786220
• UDI-Public: 05019279786220
• 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,Followup
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2022
• Device Model Number: N/A
• Device Catalogue Number: 159576
• Device Lot Number: 878490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2017
• 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): Required Intervention; Hospitalization
• Patient Sex: Female