MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PKS ANATOMIC ARCOM MENISCAL BRG - MEDIUM LEFT SIZE 5; KNEE PROSTHESIS

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 11/24/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign: france.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that patient underwent left knee revision approximately fifteen (15) years post initial surgery due to the pain which was caused by the metal marker embedded in the bearing having detached into the joint.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h10.Visual examination of the provided pictures identified that the bearing has wear on the lateral side which is the likely cause of one of the tantalum x-ray marker balls being released from the bearing.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Device is used for treatment.Radiographs were provided but were grainy and not dated therefore a hcp review would not enhance the investigation.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.

Event Description

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

• Brand Name: OXFORD PKS ANATOMIC ARCOM MENISCAL BRG - MEDIUM LEFT SIZE 5
• 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: 16101881
• MDR Text Key: 306691547
• Report Number: 3002806535-2023-00008
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279785957
• UDI-Public: (01)05019279785957(17)110822(10)1202772
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/22/2011
• Device Model Number: N/A
• Device Catalogue Number: 159549
• Device Lot Number: 1202772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2006
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male