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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFCSIGMA 3POST RDDOME PAT 41MM; SIGMA KNEE PRIMARY : KNEE PATELLA
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DEPUY ORTHOPAEDICS INC US PFCSIGMA 3POST RDDOME PAT 41MM; SIGMA KNEE PRIMARY : KNEE PATELLA Back to Search Results
Model Number 96-0113
Date of Event 10/07/2020
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
Patient was revised due to loosening of the patella at the bone to cement interface.Cement used was unknown.All 3 pegs had worn off the backside of the patella causing pain.No further information available.Doi: unknown dor: (b)(6) 2020 left knee.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
 
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Brand Name
PFCSIGMA 3POST RDDOME PAT 41MM
Common Device Name
SIGMA KNEE PRIMARY : KNEE PATELLA
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10711624
Report Number1818910-2020-22944
Device Sequence Number3933618
Product Code JWH
UDI-Device Identifier10603295232698
UDI-Public10603295232698
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K884796
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 10/07/2020
1 Device 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 Number96-0113
Device Catalogue Number960113
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/07/2020
Supplement Date Received by Manufacturer11/20/2020
Initial Report FDA Received Date10/21/2020
Supplement Report FDA Received Date11/23/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
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