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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI TIB TRAY SZ4 RMLL; EARLY INTERVENTION : KNEE TIBIAL TRAY
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DEPUY ORTHOPAEDICS INC US SIGMA HP UNI TIB TRAY SZ4 RMLL; EARLY INTERVENTION : KNEE TIBIAL TRAY Back to Search Results
Catalog Number 102452400
Medical Device Problem Code Device-Device Incompatibility (2919)
Health Effect - Clinical Code Not Applicable (3189)
Date of Event 05/03/2019
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.
 
Event or Problem Description
Insert to seat, opened alternative inserts all failed to seat.Revised implants to a total.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).This is a duplicate report of 1818910-2019-94670.1818910-2019-94669 is being retracted as it is report duplication.1818910-2019-94670 will be kept for investigation purposes.
 
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Brand Name
SIGMA HP UNI TIB TRAY SZ4 RMLL
Common Device Name
EARLY INTERVENTION : KNEE TIBIAL TRAY
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8649397
Report Number1818910-2019-94669
Device Sequence Number16209529
Product Code HRY
UDI-Device Identifier10603295002406
UDI-Public10603295002406
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K070267
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 05/07/2019
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? Yes
Operator of Device Health Professional
Device Catalogue Number102452400
Device Lot NumberHW7438
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/07/2019
Supplement Date Received by Manufacturer05/24/2019
Initial Report FDA Received Date05/29/2019
Supplement Report FDA Received Date06/03/2019
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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