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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 14MM LPS AND S-ROM : KNEE TIBIAL INSERT

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DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XXSM 14MM LPS AND S-ROM : KNEE TIBIAL INSERT Back to Search Results
Model Number 1987-27-014
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Joint Laxity (4526)
Event Date 12/29/2021
Event Type  Injury  
Event Description
It was reported that patient insert was inserted on (b)(6) 2021 and femur inserted on (b)(6) 2021. Surgeon decided to do an i&d and exploration of knee due to unexplained pain and position of patient, even had suspicion sepsis of hip due to patient presentation, hyper flexed and externally rotated. Hip aspiration was negative. Femoral component was removed as it appeared that external rotation was increased relative to where it had been placed at the previous procedure. An insert 2mm thinner was used as full extension was not obtained prior to surgery. No indication of infection were present in the knee, however specimens were sent for confirmation. Doi: (b)(6) 2021 (tibial insert), (b)(6) 2021 (femoral), dor: (b)(6) 2021, right knee. This complaint is related to (b)(4) which reports the first revision.
 
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.
 
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Brand NameLPS UNIV TIB HIN INS XXSM 14MM
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 02767 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key13250915
MDR Text Key283759164
Report Number1818910-2022-00722
Device Sequence Number1
Product Code KRO
UDI-Device Identifier10603295079347
UDI-Public10603295079347
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091453
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 01/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1987-27-014
Device Catalogue Number198727014
Device Lot NumberJ1573D
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/28/2018
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: 01/13/2022 Patient Sequence Number: 1
Treatment
LPS DISTAL FEM COMP XXSM RT; LPS UNIV TIB HIN INS XXSM 14MM; LPS XX-SM HINGE PIN
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