MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS TIBIAL INSERT SMALL 16MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6495-3-016
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's right knee was revised due to infection.A gmrs distal femur / knee was removed and a total femur (hemi acetabular implants, gmrs/ mrh knee components) was implanted.
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.The following devices were also listed in this report: gmrs proximal tib sml; cat# 64953101; lot# 187818a3; gmrs dist fem comp sml r 65mm; cat# 64952020; lot# rrs7r; mrs fem stem w/0 body 15x127mm; cat# 64853115; lot# 258802d; gmrs tib rotating sml comp; cat# 64953601; lot# 186059; gmrs extension price 70mm; cat# 64956070; lot# rcb9t; gmrs small femoral bushing; cat# 64952105; lot# lla696; gmrs small femoral bushing; cat# 64952105; lot# lky658; mrhk bumper insert - neutral; cat# 64812130; lot# lln755; mrhk tibial sleeve; cat# 64812140; lot# lkr256; gmrs small axle; cat# 64952115; lot# ctd84397; it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: GMRS TIBIAL INSERT SMALL 16MM
• 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: 17244702
• Report Number: 0002249697-2023-00739
• Device Sequence Number: 12472705
• Product Code: KRO
• UDI-Device Identifier: 07613327048827
• UDI-Public: 07613327048827
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K023087
• 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): 07/03/2023

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: 11/30/2025
• Device Model Number: 6495-3-016
• Device Catalogue Number: 64953016
• Device Lot Number: LKL098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 07/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2020
• 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: 65 YR
• Patient Sex: Male