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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI FEMORAL SZ2 LM/RL; EARLY INTERVENTION : KNEE FEMORAL
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DEPUY ORTHOPAEDICS INC US SIGMA HP UNI FEMORAL SZ2 LM/RL; EARLY INTERVENTION : KNEE FEMORAL Back to Search Results
Model Number 1024-07-200
Medical Device Problem Codes Loss of or Failure to Bond (1068); Migration (4003)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 04/07/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event or Problem Description
Revision of a depuy sigma uni knee replacement.Reason for revision was due to medial collapse/loosening of implants.All implants were removed and an attune total knee was implanted.Implants not available for return.
 
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Brand Name
SIGMA HP UNI FEMORAL SZ2 LM/RL
Common Device Name
EARLY INTERVENTION : KNEE FEMORAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11711675
Report Number1818910-2021-08477
Device Sequence Number19660538
Product Code NPJ
UDI-Device Identifier10603295001720
UDI-Public10603295001720
Combination Product (Y/N)N
Initial Reporter CountryNZ
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 04/07/2021
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? Yes
Operator of Device Health Professional
Device Model Number1024-07-200
Device Catalogue Number102407200
Device Lot NumberJ00R45
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/07/2021
Supplement Date Received by Manufacturer05/11/2021
Initial Report FDA Received Date04/22/2021
Supplement Report FDA Received Date05/12/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
SIGMA HP UNI INS SZ2 7MM LM/RL; SIGMA HP UNI TIB TRAY SZ2 LMRL; SIGMA HP UNI INS SZ2 7MM LM/RL; SIGMA HP UNI TIB TRAY SZ2 LMRL
Outcome Attributed to Adverse Event Required Intervention;
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