MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PKS C'LESS TIBIA ALPHA POROUS/HA + EXTRACTOR SLOT - RM SIZE D; KNEE PROTHESIS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094)
Date of Event	01/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a partial knee arthroplasty surgery was performed and approximately 6 years later the patient is still experiencing intermittent pain and swelling.Due diligence is in progress for this complaint; to date, no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: oxf twin peg cmntls fmrl md; item# 161474; lot# r3050584a.Oxf anat brg rt mdsize 3 pma; item# 159575; lot# 816870.Multiple mdr reports were filed for this event, please see associated reports 3002806535 - 2022 - 00290; 3002806535 - 2022 - 00291; 3002806535 - 2022 - 00292.The device history records for were reviewed for deviations and / or anomalies and no discrepancies related to the reported event were found.Review of x-ray images (6 week post-op and 3 year post-op) show overall fit, alignment, and bone quality appear normal.There are no signs of loosening, wear, radiolucency, or other contributing factors.Soft tissues are normal, no hardware or bone fractures present.There are no other concerns noted that would lead to the patient's complaint of pain/catching sensation.The root cause of the event was unable to 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.

• Brand Name: OXFORD PKS C'LESS TIBIA ALPHA POROUS/HA + EXTRACTOR SLOT - RM SIZE D
• Common Device Name: KNEE PROTHESIS
• 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: 14926783
• Report Number: 3002806535-2022-00292
• Device Sequence Number: 20384451
• Product Code: NRA
• UDI-Device Identifier: 00887868354762
• UDI-Public: (01)00887868354762(17)250422(10)R3050482A
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/22/2025
• Device Model Number: N/A
• Device Catalogue Number: US166577
• Device Lot Number: R3050482A
• 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: 06/06/2022
• Initial Report FDA Received Date: 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2015
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 75 KG