MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD TIBIAL TRAY

Model Number N/A

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

Patient Problem Pain (1994)

Event Date 02/15/2022

Event Type  Injury  

Event Description

It was reported, that: there was an oxford warranty surgery due to a patient having pain.Patient outcome: revision.

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: 3002806535-2022-00081 and 3002806535-2022-00083.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: the product has not been returned for evaluation.The item and lot number have not been provided.The investigation has been limited to the information provided.A historical search could not be performed as the item and lot number have not been provided.These devices are used for treatment.Not enough information has been provided to determine if all implants are compatible.A dhr review or a review of recalls could not be performed as the item and lot number have not been provided.The likely condition of the devices when they left zimmer biomet could not be determined as the item and lot number has not been provided.The root cause of the reported event can not be determined with the information provided.No corrective action is required at this time as the root cause of the reported event has not been determined.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2021-00081-1, 3002806535-2021-00083-1.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.

Event Description

It was reported, that there was an oxford warranty surgery due to a patient having pain.Patient outcome: revision.

• Brand Name: UNKNOWN OXFORD TIBIAL TRAY
• Type of Device: UNKNOWN OXFORD TIBIAL TRAY
• 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: 13583384
• MDR Text Key: 288597910
• Report Number: 3002806535-2022-00082
• Device Sequence Number: 1
• Product Code: HRY
• 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: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN OXFORD TIBIAL TRAY
• 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: 03/04/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female