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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
Model Number 1987-27-016
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); No Code Available (3191)
Event Date 10/22/2020
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 infection.Femoral side revision as tibial components remained as they could not be removed.A dual set up was used with thorough i&d and placement of antibiotic beads.Implants were inserted on different dates as patient had multiple surgeries.The whole distal femur was replaced including the pin.Doi: (b)(6) 2017 (femoral sleeve & stem).(b)(6) 2019 (lps adapter & distal femur).(b)(6) 2020 (patella & hinged insert).Dor: (b)(6) 2020.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
 
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Brand Name
LPS UNIV TIB HIN INS XXSM 16MM
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 Key10809280
MDR Text Key215295655
Report Number1818910-2020-24178
Device Sequence Number1
Product Code KRO
UDI-Device Identifier10603295079354
UDI-Public10603295079354
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 10/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number1987-27-016
Device Catalogue Number198727016
Device Lot NumberJ5771Y
Was Device Available for Evaluation? No
Date Manufacturer Received12/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
LPS DISTAL FEM COMP XXSM LT; LPS FEM TO SLEEVE ADAPTER +0; LPS XX-SM HINGE PIN; PFC*SIGMA/OV/DOME PAT 3PEG,38; UNIVERSAL FEM SLV FUL POR 34MM; UNIVERSAL STEM 75X14MM FLUTED; UNIVERSAL STEM 75X14MM FLUTED; UNKNOWN BONE CEMENT; UNKNOWN BONE CEMENT; LPS DISTAL FEM COMP XXSM LT; LPS FEM TO SLEEVE ADAPTER +0; LPS XX-SM HINGE PIN; PFC*SIGMA/OV/DOME PAT 3PEG,38; UNIVERSAL FEM SLV FUL POR 34MM; UNIVERSAL STEM 75X14MM FLUTED; UNIVERSAL STEM 75X14MM FLUTED; UNKNOWN BONE CEMENT; UNKNOWN BONE CEMENT
Patient Outcome(s) Required Intervention;
Patient Age70 YR
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