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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM NRH TIB PLAT ASSY XS 12MM; LPS AND S-ROM : KNEE TIBIAL INSERT
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DEPUY ORTHOPAEDICS INC US SROM NRH TIB PLAT ASSY XS 12MM; LPS AND S-ROM : KNEE TIBIAL INSERT Back to Search Results
Catalog Number 621601
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Unspecified Infection (1930); No Code Available (3191)
Date of Event 12/05/2018
Type of Reportable Event Serious Injury
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.(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
It was reported that proximal tibia was removed and xsmall 12 poly for suspected infection.
 
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Brand Name
SROM NRH TIB PLAT ASSY XS 12MM
Common Device Name
LPS AND S-ROM : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8212229
Report Number1818910-2019-79729
Device Sequence Number13952411
Product Code KRO
UDI-Device Identifier10603295178910
UDI-Public10603295178910
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K011810
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/05/2018
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 Number621601
Device Lot Number2661601B
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/05/2018
Initial Report FDA Received Date01/03/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age24 YR
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