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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XXSM 23MM; LPS AND S-ROM : KNEE TIBIAL INSERT
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DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XXSM 23MM; LPS AND S-ROM : KNEE TIBIAL INSERT Back to Search Results
Catalog Number 198727023
Medical Device Problem Codes Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes Joint Dislocation (2374); Not Applicable (3189)
Date of Event 05/28/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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
Patient was revised to address knee dislocation.It was also reported that the distal tip of insert broke off during the dislocation.Doi: unknown dor: (b)(6) 2018 unknown affected side.
 
Additional Manufacturer Narrative
(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, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
LPS UNIV TIB HIN INS XXSM 23MM
Common Device Name
LPS AND S-ROM : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key7614800
Report Number1818910-2018-62606
Device Sequence Number2074198
Product Code KRO
UDI-Device Identifier10603295079385
UDI-Public10603295079385
Combination Product (Y/N)N
Initial Reporter StateWV
Initial Reporter CountryUS
PMA/510(K) Number
K091453
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date (Section B) 05/28/2018
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 Number198727023
Device Lot NumberBFA0J60
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/28/2018
Supplement Date Received by Manufacturer07/23/2018
Initial Report FDA Received Date06/19/2018
Supplement Report FDA Received Date07/24/2018
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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