MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK KNEE FEMORAL LCS; FEMORAL

Catalog Number UNK KNEE FEMORAL LCS

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

Patient Problem Unspecified Infection (1930)

Event Date 08/05/2022

Event Type  Injury  

Event Description

The patient was revised due to loosening of the femoral component at the bone to cement interface.It was also reported that lcs explanted due to infection.Surgeon declares it is infected.No way to confirm infection.Doi: unknown; dor: (b)(6) 2022; affected side: left knee.

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK KNEE FEMORAL LCS
• Type of Device: FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15275019
• MDR Text Key: 298390856
• Report Number: 1818910-2022-16361
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: UNK KNEE FEMORAL LCS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2022
• 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 PATELLA; UNK KNEE TIBIAL INSERT LCS; UNK KNEE TIBIAL TRAY; UNKNOWN BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Sex: Male