• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 13MM XS/S S1/S2 PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 13MM XS/S S1/S2 PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 6481-3-213
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Date 11/09/2021
Event Type  Injury  
Event Description
Patient had a right tka outside cors scope in 2013, required an mua one month later. The patient developed pji with mssa and later with mrsa. Has been revised 5 times out of cors scope. In (b)(6) 2017 the patient is reimplanted, now entering cors registry. Patient develops again pji and instability. Patient undergoes resection and revision on (b)(6) 2021. Reported in cors per 7990knee covered in a separate report. Patient again presents with pji, so a resection arthroplasty is done on (b)(6) 2021, with plans of reimplantation later on. Pji persist, so patient is treated finally with an right knee arthrodesis on (b)(6) 2022.
 
Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies. There have been no other similar events for the lot referenced. An evaluation of the device cannot be performed as the device was not returned to the manufacturer. Should additional information become available it will be reported in a supplemental report upon completion of the investigation. The following devices were also listed in this report: cat# 64811111; mrh knee fem s rgt; lot# jp26e, cat# 64813110; mrh tibial b/plt keel sml 1; lot# lnn9h, cat# 5560-s-215; triathlon cemented stem-15mm x 100mm; lot# 0105704d, cat# 5560-s-115; triathlon cemented stem-15mm x 50mm; lot# 0105701h, cat# 64812110; mrhk femoral bushing; lot# lkm975, cat# 64812100; mrh tib rot comp xs-xl; lot# 172881a, cat# 64812110; mrhk femoral bushing; lot# lkm031, cat# 64812133; mrhk bumper insert 3 degrees; lot# lkp580, cat# 64812120; mrh axle; lot# ctd54902, and cat# 64812140; mrhk tibial sleeve; lot# lkm729. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
 
Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies. There have been no other similar events for the lot referenced. An evaluation of the device cannot be performed as the device was not returned to the manufacturer. Should additional information become available it will be reported in a supplemental report upon completion of the investigation. The following devices were also listed in this report: cat# 64811111; mrh knee fem s rgt; lot# jp26e, cat# 64813110; mrh tibial b/plt keel sml 1; lot# lnn9h, cat# 5560-s-215; triathlon cemented stem-15mm x 100mm; lot# 0105704d, cat# 5560-s-115; triathlon cemented stem-15mm x 50mm; lot# 0105701h, cat# 64812110; mrhk femoral bushing; lot# lkm975, cat# 64812100; mrh tib rot comp xs-xl; lot# 172881a, cat# 64812110; mrhk femoral bushing; lot# lkm031, cat# 64812133; mrhk bumper insert 3 degrees; lot# lkp580, cat# 64812120; mrh axle; lot# ctd54902, and cat# 64812140; mrhk tibial sleeve; lot# lkm729. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
 
Event Description
Patient had a right tka outside cors scope in 2013, required an mua one month later. The patient developed pji with mssa and later with mrsa. Has been revised 5 times out of cors scope. In (b)(6) 2017 the patient is reimplanted, now entering cors registry. Patient develops again pji and instability. Patient undergoes resection and revision on (b)(6) 2021. Reported in cors per 7990knee covered in a separate report. Patient again presents with pji, so a resection arthroplasty is done on (b)(6) 2021, with plans of reimplantation later on. Pji persist, so patient is treated finally with an right knee arthrodesis on (b)(6) 2022.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMRHK TIB INS 13MM XS/S S1/S2
Type of DevicePROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-LIMERICK
raheen business park
limerick NA
EI NA
Manufacturer Contact
joann ripoli
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key13598705
MDR Text Key286116128
Report Number0002249697-2022-00279
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K994207
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 02/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number6481-3-213
Device Catalogue Number64813213
Device Lot NumberLKA452
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/19/2020
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: 02/25/2022 Patient Sequence Number: 1
-
-