MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS EXTENSION PIECE 50MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 6495-6-050

Device Problem Loss of Osseointegration (2408)

Patient Problem Inadequate Osseointegration (2646)

Event Date 01/11/2023

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

A patient specific implant request was received for the patient's right distal femur.Noted on the form: ".S/p resection and reconstruction right distal femur with stryker gmrs and now second episode of aseptic loosening.Retaining 8mm large all0poly tibia." proposed date of surgery is (b)(6) 2023.

• Brand Name: GMRS EXTENSION PIECE 50MM
• Type of Device: 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16276121
• MDR Text Key: 308524117
• Report Number: 0002249697-2023-00098
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327049831
• UDI-Public: 07613327049831
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6495-6-050
• Device Catalogue Number: 64956050
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 92 KG