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)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/09/2022
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: gmrs dist fem comp sml r 65mm; cat# 64952020; lot# nx33e, mrh tibial b/plt keel sml 2; cat# 64813111; lot# n2e2j, triathlon symmetric x3 patella; cat# 5550-g-360-e; lot# pm03, triathlon sym cone aug sz c; cat# 5549-a-130; lot# cork, tri press-fit stem 13x150mm; cat# 566-s-013; lot# 0107402j, gmrs extension piece 40mm; cat# 64956040; lot# l7e2y, mrs fem stem w/o body 11x127mm; cat# 64853111; lot# 226404c, tritanium bplate triathlon s3; cat# 5536b300; lot# ctd5550, gmrs small femoral bushing; cat# 64952105; lot# lkr851, mrhk tibial sleeve; cat# 64812140; lot# lkf817, mrhk bumper insert 3 degrees; cat# 64812133; lot# llb188, mrh tib rot comp xs-xl; cat# 64812100; lot# 172823b, and gmrs small femoral bushing; cat# 64952105; lot# lkp682.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
Patient underwent primary right tka outside cors scope.On (b)(6) 2022 patient developed pji requiring revision of all components.Patient presented again with pain and signs of pji.Was revised on (b)(6) 2022.All components 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: 15974407
• Report Number: 0002249697-2022-01817
• Device Sequence Number: 5693009
• 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: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/13/2022

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
• Operator of Device: Health Professional
• Device Model Number: 6481-3-213
• Device Catalogue Number: 64813213
• Device Lot Number: LLB731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2022
• Initial Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 87 KG