MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MEDIUM KRH ALL POLY TIBIA 21MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	64852221
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: gmrs dist fem comp sml r 65mm; cat # 64952020; lot # unknown mrh xs/s/m long xover; cat # 64812103; lot # unknown 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 a krh tibial component 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: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: all stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to 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
Information received from iis 2023-001 indicates the following: pji.All components removed.Right knee.

• Brand Name: MEDIUM KRH ALL POLY TIBIA 21MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22680672
• Report Number: 0002249697-2025-00771
• Device Sequence Number: 18392369
• Product Code: JWH
• UDI-Device Identifier: 07613327047554
• UDI-Public: 07613327047554
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K972863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/31/2025

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: 64852221
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Male
• Patient Weight: 91 KG