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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA/OV/DOME PAT 3PEG,41 SIGMA KNEE PRIMARY : KNEE PATELLA

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DEPUY ORTHOPAEDICS INC US PFC*SIGMA/OV/DOME PAT 3PEG,41 SIGMA KNEE PRIMARY : KNEE PATELLA Back to Search Results
Model Number 96-0103
Device Problems Loss of or Failure to Bond (1068); Fracture (1260)
Patient Problem No Code Available (3191)
Event Date 08/11/2020
Event Type  Injury  
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 Description
Patient was revised due to patella pegs were fractured and loosening of the patellar component at the cement to implant interface. Unknown cement was used. Tibial poly exchange was performed. Doi: (b)(6) 2013 dor: (b)(6) 2020 left knee.
 
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Type of DeviceSIGMA KNEE PRIMARY : KNEE PATELLA
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JJM (SUZHOU) LTD. 3006356043
no.299 changyang st
suzhou industrial park
suzhou jiangsu 21512 -6
CH 21512-6
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key10453958
MDR Text Key204396493
Report Number1818910-2020-18779
Device Sequence Number1
Product Code JWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K96168
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 08/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number96-0103
Device Catalogue Number960103
Device Lot NumberD12062529
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 Received09/25/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2012
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: 08/26/2020 Patient Sequence Number: 1
Treatment
SIGMA XLKCVD PLUS INS 4 12.5MM
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