MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 10MM XS/S S1/S2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64813210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	11/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This report is for the revision of the patient's left knee on (b)(6) 2023.In providing information for a revision of the patient's left knee on (b)(6) 2024, rep provided usage for a prior procedure on (b)(6) 2023.Per reported patient history, patient also had prior revision on (b)(6) 2023.Per sales rep: patient was revised due to ongoing infection (reported as mrsa) as well as other comorbidities.Rep confirmed no further information will be released by the hospital or surgeon.
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 referenced.There have been 2 other similar events for the sterile lot referenced.Both events relate to infection.A review of both the sterilization data and microbiology data was performed for this sterile lot commonality.It was identified that the sterilization data was within specification and no microbiology excursions were noted for this lot and as such no further review is required.Conclusions: 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.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining 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: mrh tibial b/plt keel sml 1; cat#: 64813110; lot#: rhd9n.Tri cemented stem 12mmx50mm; cat#: 5560-s-112; lot#: 1129729l.Gmrs dist fem comp sml l 65mm; cat#: 64952010; lot#: pxn7p.Gmrs extension piece 40mm; cat#: 64956040; lot#: pal7h.Gmrs small femoral bushing; cat#: 64952105; lot#: lld350.Gmrs small femoral bushing; cat#: 64952105; lot#: lld370.Gmrs small axle; cat# 64952115; lot#: ctd84395.Mrhk bumper insert 3 degrees; cat#: 64812133; lot#: lle983.Mrh tib rot comp xs-xl; cat#: 64812100; lot#: 186027.Mrhk tibial sleeve; cat#: 64812140; lot#: lkx468.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.H3 other text: device not returned.

• Brand Name: MRHK TIB INS 10MM 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19144385
• Report Number: 0002249697-2024-00620
• Device Sequence Number: 7443721
• Product Code: KRO
• UDI-Device Identifier: 07613327043785
• UDI-Public: 07613327043785
• 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: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/19/2024

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 Catalogue Number: 64813210
• Device Lot Number: LLN156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2022
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 142 KG