MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT MD SIZE 7 PMA; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED

Model Number N/A

Device Problems Failure to Osseointegrate (1863); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inadequate Osseointegration (2646)

Event Date 09/10/2023

Event Type  Injury  

Event Description

It was reported that approximately 4 months post-op, the patient underwent revision surgery as the tibial tray had not osseointegrated into the bone, and was loose.Patient was revised to a cemented tibial tray, and the bearing was exchanged.Attempts have been made and all additional information received has been included in this report.

Manufacturer Narrative

(b)(4).D10: oxf uni tib tray sza rm; item#: 154719; lot#: 7265282.G2- new zealand.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00320.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.

Manufacturer Narrative

(b)(4).Upon review of this complaint from an investigation perspective, it is considered that the oxf anat brg rt md size 7 pma, within this complaint, does not impact the reported event.The device involved in the reported event has already been reported.See report number 3002806535 - 2023 - 00321.Given the above information, this product will now be considered an associated item.

Event Description

Upon review of this complaint from an investigation perspective, it is considered that the oxf anat brg rt md size 7 pma, within this complaint, does not impact the reported event.The device involved in the reported event has already been reported.See report number 3002806535 - 2023 - 00321.

• Brand Name: OXF ANAT BRG RT MD SIZE 7 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: 17823400
• MDR Text Key: 324322196
• Report Number: 3002806535-2023-00321
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279786251
• UDI-Public: (01)05019279786251
• 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: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• 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: 159579
• 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: 10/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose