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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TC3 RP TIBIAL INSERT S3,15.0; KNEE TIBIAL BEARING/INSERT
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DEPUY ORTHOPAEDICS, INC. 1818910 TC3 RP TIBIAL INSERT S3,15.0; KNEE TIBIAL BEARING/INSERT Back to Search Results
Catalog Number 962343
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Pain (1994)
Date of Event 09/19/2017
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 pain.
 
Additional Manufacturer Narrative
The device associated with this reported event was not received 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
TC3 RP TIBIAL INSERT S3,15.0
Common Device Name
KNEE TIBIAL BEARING/INSERT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
MDR Report Key6960982
Report Number1818910-2017-26771
Device Sequence Number633977
Product Code JDI
UDI-Device Identifier10603295242239
UDI-Public10603295242239
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K802627
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) 09/19/2017
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 Number962343
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/19/2017
Supplement Date Received by Manufacturer10/31/2017
Initial Report FDA Received Date10/19/2017
Supplement Report FDA Received Date11/10/2017
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;
Patient Age66 YR
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