MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT LG SIZE 3 PMA; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED

Catalog Number 159554

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

Patient Problems Arthritis (1723); Insufficient Information (4580)

Event Date 07/24/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10.Item#:161470 ;lot#:65677737 ;item name: oxf twin-peg cmntd fem lg pma; item#:154775 ;lot#:591490 ;item name:oxf uni tib tray sz f lm pma; item#:98-b002-006-01 ;lot#:unknown ;item name:oxf uni fm/cm tb/uni ; multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00282, 3002806535 - 2023 - 00283.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

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

Event Description

Additional information was received indicating that a revision surgery was needed due to lateral progression of the patient's arthritis.Upon review of this information, it is now considered that the oxford bearing component within this complaint has not caused or contributed to the reported event.Hence this report will be voided.

Manufacturer Narrative

(b)(4).Additional information was received indicating that a revision surgery was needed due to lateral progression of the patient's arthritis.Upon review of this information, it is now considered that the oxford bearing component within this complaint has not caused or contributed to the reported event.Given the above information this medwatch will be voided.

• Brand Name: OXF ANAT BRG LT LG SIZE 3 PMA
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED
• 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: 17583624
• MDR Text Key: 321523793
• Report Number: 3002806535-2023-00281
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279786008
• UDI-Public: (01)05019279786008(17)271128(10)65677138
• 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: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 159554
• Device Lot Number: 65677138
• 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: 11/28/2022
• 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 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male