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

Model Number N/A

Device Problem Unstable (1667)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/16/2023

Event Type  Injury  

Event Description

It was reported that patient underwent knee revision surgery due to instability about three (3) years after initial surgery.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).D10 - oxf anat brg lt md size 5 pma, item# 159549, lot# 6376325.Oxford uni twin-peg femoral md, item# 166942, lot# j6561560.G2 ¿ foreign ¿ australia.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00187, 3002806535-2023-00188.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

Upon further assessment of the reported event, it was determined that medwatch report should not have been filed as there was no indication that the device caused or contributed to a serious injury.Given this information, this medwatch report will be voided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Upon further assessment of the reported event, it was determined that medwatch report should not have been filed as there was no indication that the device caused or contributed to a serious injury.Given this information, this medwatch report will be voided.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 PROSTHESIS
• 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: 17105864
• MDR Text Key: 316942368
• Report Number: 3002806535-2023-00186
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279388868
• UDI-Public: (01)05019279388868(17)290301(10)6499378
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 154720
• Device Lot Number: 6499378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2019
• 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: 57 YR
• Patient Sex: Female
• Patient Weight: 87 KG