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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 16MM; LPS AND S-ROM : KNEE TIBIAL INSERT
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DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XSM 16MM; LPS AND S-ROM : KNEE TIBIAL INSERT Back to Search Results
Model Number 1987-27-116
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 07/24/2020
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
The patient was revised to addressed infection.Incision and drainage was done with poly exchanged.Doi: (b)(6) 2019, dor: (b)(6) 2020, affected side: right knee.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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 16MM
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 Key10367873
Report Number1818910-2020-17624
Device Sequence Number3371203
Product Code KRO
UDI-Device Identifier10603295079415
UDI-Public10603295079415
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K091453
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
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) 07/24/2020
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 Number1987-27-116
Device Catalogue Number198727116
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/24/2020
Supplement Date Received by Manufacturer09/16/2020
Initial Report FDA Received Date08/05/2020
Supplement Report FDA Received Date09/16/2020
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
LPS UNIV TIB HIN INS XSM 16MM; LPS XX-SM HINGE PIN; LPS UNIV TIB HIN INS XSM 16MM; LPS XX-SM HINGE PIN
Outcome Attributed to Adverse Event Required Intervention;
Patient Age75 YR
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