MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PKS ANATOMIC ARCOM MENISCAL BRG - SMALL RIGHT SIZE 4; KNEE ARTHROPLASTY

Model Number N/A

Device Problem Unstable (1667)

Patient Problem Failure of Implant (1924)

Event Date 05/23/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision surgery due to instability approximately 4 years after implantation.The patient has been revised from a 4mm bearing to a 6mm bearing.No additional information is available at this time.

Manufacturer Narrative

(b)(4).Report source foreign: (b)(6).Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: overall fit appears normal.There is slight narrowing of the medial joint space.The level of the articular surface of the medial tibial plate appears slightly inferior with respect to the lateral tibial plateau.Revision could be performed to increase spacing.The bones appear well mineralized.There are no hardware or bone fractures and soft tissue appears within normal limits.There are no signs of loosening, wear, radiolucency, or other contributing factors.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: OXFORD PKS ANATOMIC ARCOM MENISCAL BRG - SMALL RIGHT SIZE 4
• Type of Device: KNEE ARTHROPLASTY
• 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: 14796632
• MDR Text Key: 294655736
• Report Number: 3002806535-2022-00283
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279786152
• UDI-Public: (01)05019279786152(17)220407(10)6029812
• 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: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/07/2022
• Device Model Number: N/A
• Device Catalogue Number: 159569
• Device Lot Number: 6029812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2017
• 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 Sex: Female
• Patient Weight: 74 KG