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	05/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding infection involving an mrh insert was reported.The event was not confirmed.Method & results: device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: not performed as no medical records were received for review with a clinical consultant.Device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been one similar event for the lot referenced.There have been no other similar event for sterile lot referenced.Conclusion: it was reported that the patient was revised due to infection.All stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance with applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Additional information including pathology reports, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.The following devices were also listed in this report: cat# 64812130; mrhk bumper insert - neutral: lot# lle974; cat# 64812140; mrhk tibial sleeve; lot# llb243; cat# 64952105; gmrs small femoral bushing; lot# lky643; qty 2; cat# 64952115; gmrs small axle; lot# ctd72125; cat# unknown; unknown gmrs extension piece; lot# unknown; cat# 5549-a-130; triathlon sym cone aug sz c; lot# p57e1; cat# 64813111; mrh tibial b/plt keel sml 2; lot# pxh9a; cat# 64786600; ti dur reg fluted stem 10x80mm; lot# 0101166; cat# 64952020; gmrs dist fem comp sml r 65mm; lot# pxp2l; cat# 64812100; mrh tib rot comp xs-xl; lot# 185970.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
It was reported that the patient's right knee was revised.As reported: "pt.Presented with clinical signs of infection.Dr.Performed an ¿extensive i&d¿ and swap of some gmrs/mrh components.No complaints filed against the components themselves, no further info available." bushings, inserts, sleeve and axle (implanted (b)(6) 2022), and an extension piece (implant date unknown) were revised.
Additional Manufacturer Narrative
The following devices were also listed in this report: cat# 64812130; mrhk bumper insert - neutral: lot# lle974 cat# 64812140; mrhk tibial sleeve; lot# llb243 cat# 64952105; gmrs small femoral bushing; lot# lky643; qty 2 cat# 64952115; gmrs small axle; lot# ctd72125 cat# 64956040; gmrs extension piece 40mm; lot# uxssu cat# 5549-a-130; triathlon sym cone aug sz c; lot# p57e1 cat# 64813111; mrh tibial b/plt keel sml 2; lot# pxh9a cat# 64786600; ti dur reg fluted stem 10x80mm; lot# 0101166 cat# 64952020; gmrs dist fem comp sml r 65mm; lot# pxp2l cat# 64812100; mrh tib rot comp xs-xl; lot# 185970.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience reported event: an event regarding infection involving an mrh insert was reported.The event was not confirmed.Method & results: device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: not performed as no medical records were received for review with a clinical consultant.Device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been one similar event for the lot referenced.There have been no other similar event for sterile lot referenced.Conclusion: it was reported that the patient was revised due to infection.All stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance with applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided. additional information including pathology reports, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
It was reported that the patient's right knee was revised.As reported: "pt.Presented with clinical signs of infection.Dr.Performed an ¿extensive i&d¿ and swap of some gmrs/mrh components.No complaints filed against the components themselves, no further info available." bushings, inserts, sleeve and axle (implanted (b)(6) 2022), and an extension piece (implant date unknown) were revised.

• 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, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 17122886
• Report Number: 0002249697-2023-00664
• Device Sequence Number: 15067384
• Product Code: KRO
• UDI-Device Identifier: 07613327043792
• UDI-Public: 07613327043792
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

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: 07/31/2026
• Device Model Number: 6481-3-213
• Device Catalogue Number: 64813213
• Device Lot Number: LKY021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2021
• 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: 44 YR
• Patient Sex: Male