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

Model Number N/A

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

Patient Problem Insufficient Information (4580)

Event Date 08/31/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item#:161469; lot#: unknown; itemname: oxf twin-peg cmntd fem md pma; item#:159548; lot#: unknown; itemname: oxf anat brg lt md size 4 pma.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 -00407, 3002806535 -2022 -00409.

Event Description

It was reported that the patient underwent revision surgery due to an unknown reason.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

Cmp-(b)(4).D10: item#:161469; lot#: 813400; itemname: oxf twin-peg cmntd fem md pma; item#:159548; lot#: 3063641; itemname: oxf anat brg lt md size 4 pma this follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, d10, g3, g6, h2, h4, h6, h10.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.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: OXF UNI TIB TRAY SZ B LM PMA
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL
• 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: 15500358
• MDR Text Key: 300764943
• Report Number: 3002806535-2022-00406
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279388868
• UDI-Public: (01)05019279388868(17)230925(10)645800
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/25/2023
• Device Model Number: N/A
• Device Catalogue Number: 154720
• Device Lot Number: 645800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 COMMENTS; SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female