MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 13MM M/L M2/L2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6481-3-313
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding infection involving a mrh insert was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot or sterile lot referenced.Conclusion: all stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance to applicable iso standards.Further information such as return of the device, pathology reports, operative report as well as patient history and follow-up notes are needed to confirm the event and determine a root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.The following devices were also listed in this report: gmrs extension piece 40mm; cat# 64956040; lot# ly47n.Mrh axle; cat# 64812120; lot# ctd62951.Mrhk femoral bushing; cat# 64812110; lot# lkm975.Mrhk tibial sleeve; cat# 64812140; lot# lkm485.Mrhk bumper insert 3 degrees; cat# 64812133; lot# lkm740.Mrh tib rot comp xs-xl; cat# 64812100; lot# 179085a.Mrhk femoral bushing; cat# 64812110; lot# lkh493.Gmrs dist fem comp std l 65mm; cat# 64952030; lot# lns7d.Mrh tibial b/plt keel med 2; cat# 64813112; lot# l3y3a.Triathlon sym cone aug sz e; cat# 5549-a-150; lot# t1hy1.Mrs fem stem w/o body 13x127mm; cat# 64853113 ; lot# 239029d.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.H3 other text : not returned.
Event or Problem Description
This pi is for revision on (b)(6) 2022.The patient had an index left tka outside of cors scope.The patient developed pji in the left knee and underwent revision with a gmrs system for pji with all components exchanged on (b)(6) 2021 (then included into cors).The patient developed pji again and was revised with femur and all rotating hinge components exchanges on (b)(6) 2021.The patient presents with signs of infection and again undergoes l tka revision on (b)(6) 2022, with all rotating components exchanged.

• Brand Name: MRHK TIB INS 13MM M/L M2/L2
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16944034
• Report Number: 0002249697-2023-00535
• Device Sequence Number: 2189185
• Product Code: KRO
• UDI-Device Identifier: 07613327043846
• UDI-Public: 07613327043846
• 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: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2023

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: 03/31/2026
• Device Model Number: 6481-3-313
• Device Catalogue Number: 64813313
• Device Lot Number: LKP935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2023
• Initial Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2021
• 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: Required Intervention; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 100 KG