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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIVERSAL STEM 75X12MM FLUTED; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS
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DEPUY ORTHOPAEDICS INC US UNIVERSAL STEM 75X12MM FLUTED; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS Back to Search Results
Model Number 86-7412
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 03/01/2021
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
The patient was revised due to infection.All implants were removed.Doi: (b)(6) 2019; dor: (b)(6) 2021; right knee.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.
 
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Brand Name
UNIVERSAL STEM 75X12MM FLUTED
Common Device Name
UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11455947
Report Number1818910-2021-04870
Device Sequence Number14393420
Product Code JWH
UDI-Device Identifier10603295217817
UDI-Public10603295217817
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 03/01/2021
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 Model Number86-7412
Device Catalogue Number867412
Device Lot NumberJ14Z96
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/01/2021
Supplement Date Received by Manufacturer04/15/2021
Initial Report FDA Received Date03/10/2021
Supplement Report FDA Received Date04/18/2021
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
LCS COM DSTL AUG 5MM STD+ RT; LCS COM POST AUG 5MM STD+; LCS COM POST AUG 5MM STD+; LCS COMP RPS INS STD+ 20MM; LCS COMPLETE REVFEM CEM R STD+; MBT REV TIB TRAY SIZE 3 15MM; MBT TRAY SLEEVE POR M/L 45MM; SMARTSET GMV 40G US EO; UNIVERSAL FEM SLV DIS POR 31MM; UNIVERSAL STEM 75X12MM FLUTED; UNIVERSAL STEM 75X16MM FLUTED
Outcome Attributed to Adverse Event Required Intervention;
Patient Age63 YR
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