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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE FEMORAL SLEEVE UNK KNEE FEMORAL SLEEVE Back to Search Results
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.
 
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Brand NameUNKNOWN KNEE FEMORAL SLEEVE
Type of DeviceUNK KNEE FEMORAL SLEEVE
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
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9959013
MDR Text Key187596049
Report Number1818910-2020-10751
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
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 Received04/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK KNEE FEMORAL SLEEVE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/19/2020
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 Treatment Data
Date Received: 04/14/2020 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
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