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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMA MOD TIB TRAY CEM SZ5; SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY
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DEPUY ORTHOPAEDICS INC US PFC SIGMA MOD TIB TRAY CEM SZ5; SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY Back to Search Results
Catalog Number 866025
Medical Device Problem Code Loss of or Failure to Bond (1068)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 11/20/2018
Type of Reportable Event Serious Injury
Additional 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.(b)(4).
 
Event or Problem Description
The patient was revised to address loosening of the tibial component at cement to implant interface.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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 SIGMA MOD TIB TRAY CEM SZ5
Common Device Name
SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key8164103
Report Number1818910-2018-78196
Device Sequence Number1850840
Product Code JWH
UDI-Device Identifier10603295216803
UDI-Public10603295216803
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K884796
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 11/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Operator of Device Health Professional
Device Catalogue Number866025
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/20/2018
Supplement Date Received by Manufacturer12/20/2018
Initial Report FDA Received Date12/14/2018
Supplement Report FDA Received Date12/23/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 Yes
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age79 YR
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