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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/R NPOR FEM RT SZ 3; SIGMA KNEE PRIMARY : KNEE FEMORAL
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DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/R NPOR FEM RT SZ 3; SIGMA KNEE PRIMARY : KNEE FEMORAL Back to Search Results
Model Number 96-0013
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Joint Laxity (4526)
Date of Event 04/12/2021
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 illegible information appropriate.
 
Event or Problem Description
The patient was revised to address instability.No surgical delay.Doi: (b)(6) 2018, dor: (b)(6) 2021, right 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 at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
 
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Common Device Name
SIGMA KNEE PRIMARY : KNEE FEMORAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11716871
Report Number1818910-2021-08599
Device Sequence Number17041950
Product Code JWH
UDI-Device Identifier10603295232025
UDI-Public10603295232025
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
K943462
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2021
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) 04/12/2021
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? No
Operator of Device Health Professional
Device Model Number96-0013
Device Catalogue Number960013
Device Lot NumberD18060426
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/12/2021
Supplement Date Received by Manufacturer05/21/2021
Initial Report FDA Received Date04/23/2021
Supplement Report FDA Received Date05/24/2021
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
PFC*SIGMA C/R NPOR FEM RT SZ 3; SIG MOD TIB TRAY CEM COCR 2.5; SIGMA PLI XLK INS 2.5 12.5MM
Outcome Attributed to Adverse Event Required Intervention;
Patient Age73 YR
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