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

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

Patient Problems Pain (1994); Synovitis (2094)

Event Date 01/27/2022

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 295310212
• Report Number: 3002806535-2022-00292
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 00887868354762
• UDI-Public: (01)00887868354762(17)250422(10)R3050482A
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• 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
• Date Manufacturer Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2015
• 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): Other
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 75 KG