MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT MD SIZE 4 PMA; OXFORD HXLPE BEARINGS

Model Number N/A

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

Patient Problems Arthritis (1723); Pain (1994)

Event Date 03/22/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 ¿ medical devices: oxf uni tib tray sz c rm pma; item# 154723; lot# 197130.Oxf twin-peg cmntd fem md pma; item# 161469; lot# 252880.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00112, 3002806535 - 2023 - 00113, 3002806535 - 2023 - 00114.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 patient underwent initial uni knee arthroplasty and approximately 8 (eight) years later a revision surgery was performed due to pain and lateral wear.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.It was reported the patient was revised for progression of osteoarthritis.Disease progression of osteoarthritis can continue in native bone structures as a patient continues to age.Other patient comorbidities, lifestyle, physical activities and some medications can increase the patients risk for progressive osteoarthritis.Partial knee replacement is done to decrease pain, and increase flexibility, mobility and overall improve quality of life as this is one of the least invasive approaches.Patients with disease progression of osteoarthritis in the affected joint develop knee pain, and decrease in joint flexibility.As osteoarthritis progresses a loss of cartilage in the previously unaffected area of the knee has deteriorated to a point in which the patient and doctor may elect to take an approach to convert to a full-knee replacement to alleviate symptoms.Medical records were provided and reviewed.The provided medical notes stated "well fixed, well positioned medial compartment uka.Lateral compartment demonstrates some progression of arthritis with arthritic progression in the patellofemoral joint as well.The products are deemed to be conforming to specification and the patients medical notes report progression of arthritis therefore, the root cause of the reported issue is attributed to disease progression.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: OXF ANAT BRG RT MD SIZE 4 PMA
• Type of Device: OXFORD HXLPE BEARINGS
• 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: 16730384
• MDR Text Key: 313189445
• Report Number: 3002806535-2023-00114
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279786220
• UDI-Public: (01)05019279786220(17)190926(10)717420
• 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: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/26/2019
• Device Model Number: N/A
• Device Catalogue Number: 159576
• Device Lot Number: 717420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2014
• 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): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 57 KG