MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS PROXIMAL TIBIAL STANDARD; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64953102
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	04/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: this pi is for the 2021 revision: as per pss case: loosening right distal tibia.1st surgery gmrs proximal tibia with cemented stem (b)(6) 2019.2nd surgery longer extension with 17mm cementless stem (b)(6) 2021.Requesting custom made stem.Cementless 7cm in length.Update: this pi is for the 2021 revision: as per pss case: loosening right proximal tibia stem.1st surgery gmrs proximal tibia and distal femur with cemented stems (b)(6) 2019.2nd surgery revision of loose cemented femur stem with cementless stem (b)(6) 2021.Requesting custom made stem.Shot tibial stem cementless 7cm in length.
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There has been similar event(s) for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

• Brand Name: GMRS PROXIMAL TIBIAL STANDARD
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24616798
• Report Number: 0002249697-2026-00179
• Device Sequence Number: 21416109
• Product Code: KRO
• UDI-Device Identifier: 07613327048865
• UDI-Public: 07613327048865
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: K023087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2026

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: 08/31/2023
• Device Catalogue Number: 64953102
• Device Lot Number: 126623C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2018
• 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: 20 YR
• Patient Sex: Male
• Patient Weight: 82 KG