MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ C LM PMA; KNEE PROSTHESIS

Model Number	154722
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent initial oxford uni knee surgery.Approximately 5 years later a revision surgery was performed due pain.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).Medical device: oxf anat brg lt sm size 3 pma; item# 159540; lot# 989610.Oxf twin-peg cmntd fem sm pma; item# 161468; lot# 101130.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2022 - 00428, 3002806535 - 2022 - 00430.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.Sent for cultures.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h6, h10.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 patient's 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.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: OXF UNI TIB TRAY SZ C LM PMA
• Common Device Name: 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: 15602767
• Report Number: 3002806535-2022-00429
• Device Sequence Number: 2328092
• Product Code: NRA
• UDI-Device Identifier: 05019279388882
• UDI-Public: (01)05019279388882(17)261209(10)336710
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 154722
• Device Catalogue Number: 154722
• Device Lot Number: 336710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Prefer Not To Disclose