MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 20MM XS/S S1/S2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 6481-3-220

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 08/03/2021

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.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.The following devices were also listed in this report: mrhk tibial sleeve; cat#64812140; lot#lkl786 ,mrh tib rot comp xs-xl; cat#64812100; lot#167626a ,mrhk bumper insert 3 degrees; cat#64812133;lot#lkp578 ,mrh axle; cat# 64812120ctd;lot#54907 ,mrhk femoral bushing; cat#64812110;lot#lkl435 ,mrhk femoral bushing; cat#64812110;lot#lkm029 ,mrh knee fem xs rht; cat#64811101; lot#jsl3b ,mrh tibial b/plt keel sml 1; cat#64813110; lot#lxr9s ,triathlonctrfemconeaug sz3&4r; cat#5549-a-642; lot#k1ej ,triathlon sym cone aug sz b; cat#5549-a-120; lot#p9pp1 ,tri press-fit stem 16mm x 100mm; cat#5565-s-016; lot#0081917a ,tri press-fit stem 10mm x 100mm; cat#5565-s-010; lot#0083056e ,mrhk fem distal blk 10mm xs; cat#64811200; lot#jba2d ,mrhk fem distal blk 10mm xs; cat#64811200; lot#j9x9a ,and it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

Patient underwent right index tka outside cors scope.On (b)(6) 2021 patient presents with pain and is studied for infection.She is revised for pji on (b)(6) 2021.Liner and all rotating components were exchanged.

• Brand Name: MRHK TIB INS 20MM XS/S S1/S2
• Type of Device: PROSTHESIS, 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13732803
• MDR Text Key: 287015812
• Report Number: 0002249697-2022-00375
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327043839
• UDI-Public: 07613327043839
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994207
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6481-3-220
• Device Catalogue Number: 64813220
• Device Lot Number: LKH227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2022
• Initial Date FDA Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White