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

Model Number	6481-3-213
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Date of Event	09/27/2021
Type of Reportable Event	Serious Injury
Additional 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.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.The following devices were also listed in this report: mrh knee fem xs rht; cat# 64811101; lot# h2d9r.Tri press-fit stem 20mm x 100mm; cat# 5565-s-020; lot# 0071326k.Mrhk fem distal blk 10mm xs; cat# 64811200; lot#e247h.Mrh axle; cat# 64812120; lot# ctd41816.Mrh tib rot comp xs-xl; cat# 64812100; lot#158505.Mrhk bumper insert 3 degrees; cat# 64812133; lot# ljk485.Mrhk femoral bushing; cat# 64812110; lot# ljm917.Mrhk tibial sleeve; cat# 64812140; lot# ljl214.Mrh tibial b/plt keel sml; cat# 64813110; lot#h2d3r.Triathlon sym cone aug sz b; cat# 5549-a-120; lot#h7ha.Tri press-fit stem 13mm x 100mm; cat# 5565-s-013 ; lot# 0060834j.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Patient underwent right index tka outside of cors scope.Patient presents with pain and disruption extensor mechanism.She is revised for pji on (b)(6) 2019, all components were exchanged.Patient presents again.She is studied for infection.Patient is revised on (b)(6) 2021 for pji.Femoral and liner, and rotating components are exchanged.

• Brand Name: MRHK TIB INS 13MM 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 13765742
• Report Number: 0002249697-2022-00388
• Device Sequence Number: 3822421
• Product Code: KRO
• UDI-Device Identifier: 07613327043792
• UDI-Public: 07613327043792
• 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: 2021
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2022

1 Device 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: 08/31/2024
• Device Model Number: 6481-3-213
• Device Catalogue Number: 64813213
• Device Lot Number: LJK236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial