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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFC KEEL TIB TRAY CEM SZ3; KNEE TIBIAL TRAY
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DEPUY ORTHOPAEDICS, INC. 1818910 PFC KEEL TIB TRAY CEM SZ3; KNEE TIBIAL TRAY Back to Search Results
Catalog Number 864181
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 10/12/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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 to address infection.
 
Additional Manufacturer Narrative
The device associated with this reported event was not returned for examination.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
PFC KEEL TIB TRAY CEM SZ3
Common Device Name
KNEE TIBIAL TRAY
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
MDR Report Key7017748
Report Number1818910-2017-28685
Device Sequence Number19071604
Product Code JWH
UDI-Device Identifier10603295216438
UDI-Public10603295216438
Combination Product (Y/N)N
Initial Reporter StateKS
Initial Reporter CountryUS
PMA/510(K) Number
K830927
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date (Section B) 10/12/2017
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 Catalogue Number864181
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/12/2017
Supplement Date Received by Manufacturer11/14/2017
Initial Report FDA Received Date11/10/2017
Supplement Report FDA Received Date11/24/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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