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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 16MM LPS AND S-ROM : KNEE TIBIAL INSERT

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DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XXSM 16MM LPS AND S-ROM : KNEE TIBIAL INSERT Back to Search Results
Catalog Number 198727016
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Joint Laxity (4526); Insufficient Information (4580)
Event Date 12/15/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint # (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 dislocating hinge. Only poly and pin was revised. Doi: unknown. Dor: (b)(6) 2021. Unknown knee side.
 
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Brand NameLPS UNIV TIB HIN INS XXSM 16MM
Type of DeviceLPS AND S-ROM : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655
325 paramount drive
raynham MA 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key13265902
MDR Text Key283946451
Report Number1818910-2022-00941
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K091453
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 01/17/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/17/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number198727016
Device Lot Number575270
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/31/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/24/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/17/2022 Patient Sequence Number: 1
Treatment
LPS XX-SM HINGE PIN; UNK KNEE TIBIAL INSERT LPS
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