MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 16MM XS/S S1/S2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 6481-3-216

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 03/06/2020

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: mrh knee fem xs lft;64811100;cxr2y; mrh tibial b/plt keel sml 1;64813110;dsj6e; triathlon symmetric x3 patella;5550-g-339;4lex; mrh tib rot comp xs-xl;64812100;131813; triathlon fem cone aug sz 5l;5549-a-351;a62d; triathlon sym cone aug sz c;5549-a-130;dy91; mrhk fem distal blk 10mm xs;64811200;csh6e; mrhk fem distal blk 10mm xs;64811200;a423p; tri press-fit stem 13x150mm;5566-s-013;0045962a; tri press-fit stem 11mm x 100mms;5565-s-011;0055142d; mrhk femoral bushing;64812110;lhj106; mrhk femoral bushing;64812110;lhq890; mrh axle;64812120;ctd29350; mrhk tibial sleeve;64812140;lhn776; mrhk bumper insert 3 degrees;64812133;lhh023.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.

Event Description

Procedure: the patient underwent left total knee revision due to infection associated with internal left knee prosthesis (b)(6) 2019.Patient underwent new revision of left total knee arthroplasty due to pji, all components changed (b)(6) 2020.

• Brand Name: MRHK TIB INS 16MM 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 ; IE NA
• Manufacturer Contact: alessandra chavez ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 10478549
• MDR Text Key: 205260999
• Report Number: 0002249697-2020-01775
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327043808
• UDI-Public: 07613327043808
• 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: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 6481-3-216
• Device Catalogue Number: 64813216
• Device Lot Number: LHL766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2018
• 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: 80 YR
• Patient Weight: 92