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

Catalog Number UNK KNEE FEMORAL SLEEVE

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

Patient Problems Wound Dehiscence (1154); Necrosis (1971); No Code Available (3191)

Event Date 03/06/2020

Event Type  Injury  

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.

Event Description

It was reported that the patient received a right knee irrigation and debridement with a medial gastrocnemius muscle rotational flap to treat postoperative wound necrosis with wound dehiscence status post depuy hinged knee revision.The necrotic tissue was debrided, and the soft tissue repaired with the muscle flap.The would was fitted with a wound vac.No infection was detected, and no components were revised.The procedure was completed without complications.Doe: (b)(6) 2020; right knee.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional 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 device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN KNEE FEMORAL SLEEVE
• Type of Device: UNK KNEE FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9959013
• MDR Text Key: 187596049
• Report Number: 1818910-2020-10751
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE FEMORAL SLEEVE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK KNEE FEMORAL COMPONENT; UNK KNEE FEMORAL SLEEVE; UNK KNEE FEMORAL STEM; UNK KNEE PATELLA; UNK KNEE TIBIAL INSERT; UNK KNEE TIBIAL SLEEVE; UNK KNEE TIBIAL STEM; UNK KNEE TIBIAL TRAY; UNK KNEE FEMORAL COMPONENT; UNK KNEE FEMORAL SLEEVE; UNK KNEE FEMORAL STEM; UNK KNEE PATELLA; UNK KNEE TIBIAL INSERT; UNK KNEE TIBIAL SLEEVE; UNK KNEE TIBIAL STEM; UNK KNEE TIBIAL TRAY
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR