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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 XSM 23MM; LPS AND S-ROM : KNEE TIBIAL INSERT
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DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XSM 23MM; LPS AND S-ROM : KNEE TIBIAL INSERT Back to Search Results
Model Number 1987-27-123
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Pain (1994); No Code Available (3191)
Date of Event 06/11/2020
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
Patient was revised to address pain.Do not have part numbers for implants.All available information has been provided.Doi: (b)(6) 2017 dor: (b)(6) 2020 right knee.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.
 
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Brand Name
LPS UNIV TIB HIN INS XSM 23MM
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 Key10190822
Report Number1818910-2020-14348
Device Sequence Number11439842
Product Code KRO
UDI-Device Identifier10603295079446
UDI-Public10603295079446
Combination Product (Y/N)N
Initial Reporter StateMD
Initial Reporter CountryUS
PMA/510(K) Number
K091453
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 06/11/2020
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? No
Operator of Device Health Professional
Device Model Number1987-27-123
Device Catalogue Number198727123
Device Lot Number503413
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/11/2020
Supplement Date Received by Manufacturer07/27/2020
Initial Report FDA Received Date06/24/2020
Supplement Report FDA Received Date07/28/2020
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
HINGE PIN; LPS CEM FEM STEM 14X150MM BOW; LPS DISTAL FEM COMP XSM RT; LPS SEGMENTAL COMPONENT 25MM; HINGE PIN; LPS CEM FEM STEM 14X150MM BOW; LPS DISTAL FEM COMP XSM RT; LPS SEGMENTAL COMPONENT 25MM
Outcome Attributed to Adverse Event Required Intervention;
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