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
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	03/06/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10478549
• Report Number: 0002249697-2020-01775
• Device Sequence Number: 16795661
• Product Code: KRO
• UDI-Device Identifier: 07613327043808
• UDI-Public: 07613327043808
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K994207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2020

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 92