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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 18MM LPS AND S-ROM : KNEE TIBIAL INSERT

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DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XXSM 18MM LPS AND S-ROM : KNEE TIBIAL INSERT Back to Search Results
Model Number 1987-27-018
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Ambulation Difficulties (2544)
Event Date 06/02/2017
Event Type  Injury  
Event Description
The patient was revised due to aseptic loosening. Doi: unknown, dor: (b)(6) 2021, unknown knee side.
 
Manufacturer Narrative
(b)(4). The devices are reported under (b)(4) as the patient experienced adverse events on different days with the same devices. 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 18MM
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
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key13534869
MDR Text Key285617088
Report Number1818910-2022-02830
Device Sequence Number1
Product Code KRO
UDI-Device Identifier10603295079361
UDI-Public10603295079361
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
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1987-27-018
Device Catalogue Number198727018
Device Lot Number360612
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/28/2013
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: 02/15/2022 Patient Sequence Number: 1
Treatment
ALLOSOURCE MISCELLANEOUS TISSUE 104682109; LPS DISTAL FEM COMP XXSM LT; LPS FEM TO SLEEVE ADAPTER +5; LPS SEGMENTAL COMPONENT 45MM; LPS UNIV TIB HIN INS XXSM 18MM; MBT REV TIB TRAY SIZE 2 25MM; MBT TRAY SLEEVE POR M/L 61MM; STRYKER CEMENT; STRYKER CEMENT 61971001; STRYKER CEMENT 61971001; STRYKER CEMENT 61971001; STRYKER CEMENT 61971001; STRYKER CEMENT 61971001; UNIVERSAL FEM SLV FUL POR 34MM; UNIVERSAL STEM 75X16MM FLUTED; UNIVERSAL STEM 75X20MM FLUTED
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