MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNKNOWN KNEE FEMORAL

Catalog Number UNK KNEE FEMORAL

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

Patient Problems Adhesion(s) (1695); Loss of Range of Motion (2032); Joint Laxity (4526)

Event Date 07/08/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint (b)(4).D4: the device catalog number is unknown.Therefore, udi is unavailable.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information, which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained, that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported, that the hospital noticed an increased sinking of the attune revisions fb tibia, during their checks.These must be reoperated.(b)(4), translation request was reviewed by clinician.On (b)(6) 2019, depuy attune components were implanted in the right knee to address gonarthrosis.On (b)(6) 2020, the patient had a complete change of the total knee prosthesis on the right.From a primary attune to an attune revision to address increasing hyperextension and laxity.The surgeon was able to subluxate the rotating inlay.During the procedure, the surgeon had to loosen adhesions.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the reporter reported, the hospital noticed an increased sinking of the attune revisions fb tibia during their checks.These must be reoperated.Of 30 restorations, 5 have to be or had to be revised.The product was not returned to depuy synthes, however photos were provided for review.The x-ray investigation revealed nothing indicative of a device nonconformance.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the unknown knee femoral would not contribute to the reported adverse event.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : the device lot number is unknown, therefore a device history review could not be performed.If more information become available, the record will be re-assessed.

• Brand Name: UNKNOWN KNEE FEMORAL
• Type of Device: KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19041614
• MDR Text Key: 339436005
• Report Number: 1818910-2024-07570
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE FEMORAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: 03/22/2024; 04/12/2024
• Supplement Dates FDA Received: 04/04/2024; 04/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK KNEE TIBIAL TRAY ATTUNE FB; UNKNOWN KNEE TIBIAL INSERT
• Patient Outcome(s): Required Intervention