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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 14MM; LPS AND S-ROM : KNEE TIBIAL INSERT

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DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XSM 14MM; LPS AND S-ROM : KNEE TIBIAL INSERT Back to Search Results
Model Number 1987-27-114
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/27/2021
Event Type  Injury  
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 Description
Patient was revised due to infected knee.Washout and poly exchange was done.Doi: unknown, dor: (b)(6) 2021, right knee.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
 
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Brand Name
LPS UNIV TIB HIN INS XSM 14MM
Type of Device
LPS AND S-ROM : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12336837
MDR Text Key267078562
Report Number1818910-2021-18073
Device Sequence Number1
Product Code KRO
UDI-Device Identifier10603295079408
UDI-Public10603295079408
Combination Product (y/n)N
PMA/PMN Number
K091453
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/27/2021
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
Device Operator Health Professional
Device Model Number1987-27-114
Device Catalogue Number198727114
Device Lot NumberBFAOVXP
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/27/2021
Initial Date FDA Received08/18/2021
Supplement Dates Manufacturer Received08/25/2021
Supplement Dates FDA Received08/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
LPS UNIV TIB HIN INS XSM 14MM; LPS XX-SM HINGE PIN; LPS UNIV TIB HIN INS XSM 14MM; LPS XX-SM HINGE PIN
Patient Outcome(s) Required Intervention;
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