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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIVERSAL FEM SLV FUL POR 46MM; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE FEMORAL ACCESSORY
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DEPUY ORTHOPAEDICS INC US UNIVERSAL FEM SLV FUL POR 46MM; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE FEMORAL ACCESSORY Back to Search Results
Model Number 1294-53-246
Medical Device Problem Codes Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 01/01/2019
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 appropriate.
 
Event or Problem Description
Fracture of s-rom noiles femoral stem left side.Doi: 2017 in another hospital.Dor (planned): (b)(6) 2019.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned devices confirmed the reported event.No product problem has been identified.This device was manufactured on 19-dec-2016.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.The previous device code (fracture) reported is being retracted since it was incorrectly submitted in the initial medwatch.
 
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Brand Name
UNIVERSAL FEM SLV FUL POR 46MM
Common Device Name
UNIVERSAL KNEE STEMS AND SLEEVES : KNEE FEMORAL ACCESSORY
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10198252
Report Number1818910-2020-14471
Device Sequence Number1019965
Product Code JWH
UDI-Device Identifier10603295026365
UDI-Public10603295026365
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K063633
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) 06/10/2020
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 Model Number1294-53-246
Device Catalogue Number129453246
Device Lot NumberH22696
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2020
Initial Date Received by Manufacturer 06/10/2020
Supplement Date Received by Manufacturer07/16/2020
Initial Report FDA Received Date06/25/2020
Supplement Report FDA Received Date07/17/2020
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
MBT REVISION CEM TIB TRAY SZ 2; MBT TRAY SLEEVE POR M/L 61MM; SROM NRHFEM W/PIN SM LFT 66X62; UNIVERSAL STEM 150X16MM FLUTED; MBT REVISION CEM TIB TRAY SZ 2; MBT TRAY SLEEVE POR M/L 61MM; SROM NRHFEM W/PIN SM LFT 66X62; UNIVERSAL STEM 150X16MM FLUTED
Outcome Attributed to Adverse Event Required Intervention;
Patient Age72 YR
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