MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ B LM PMA; KNEE PROTHESIS

Model Number N/A

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

Patient Problem Insufficient Information (4580)

Event Date 10/03/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent conversion of partial to total knee implant due to unknown reason, approximately 4 years after initial implantation.Due diligence is in progress for this event; to date no further information has been provided.

Manufacturer Narrative

(b)(4).Concomitant medical products: oxf twin-peg cmntd fem sm pma item#161468, lot#113140 oxf anat brg lt sm size 3 pma item#159540 lot#299880.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2022-00438, 3002806535-2022-00440.

Event Description

It was reported that the patient underwent conversion of partial to total knee implant due to lateral joint disease, approximately 4 years after initial implantation.No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Device is used for treatment.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OXF UNI TIB TRAY SZ B LM PMA
• Type of Device: KNEE PROTHESIS
• 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: 15698111
• MDR Text Key: 302689595
• Report Number: 3002806535-2022-00439
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279388868
• UDI-Public: (01)05019279388868(17)280607(10)000450
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 154720
• Device Lot Number: 000450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2018
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization
• Patient Sex: Prefer Not To Disclose