MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD BEARING

Model Number N/A

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Joint Laxity (4526)

Event Date 04/20/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.The client has indicated that the product will not be returned to zimmer biomet for an investigation.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2022-00232, 3002806535-2022-00233.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.

Event Description

It was reported, that: there was an oxford warranty case due to instability and pain.Patient outcome: revision.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: concomitant medical product: unknown oxford tibial component: catalog#ni, lot#ni; oxford uni femoral sm: catalog#154600, lot#1535198.The reported event has not been confirmed as the products have not been returned for evaluation.Device history record was unable to be performed as the lot number of the device involved in the event is unknown.The definitive root cause of the reported event cannot be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : see h10 narrative.

Event Description

No further event information at time of this report.

• Brand Name: UNKNOWN OXFORD BEARING
• Type of Device: UNKNOWN OXFORD
• 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: 14235949
• MDR Text Key: 290269613
• Report Number: 3002806535-2022-00234
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• 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: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN OXFORD BEARING
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female