MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS TIBIAL INSERT SMALL 10MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6495-3-010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/12/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
This pi is for revision due to infection on (b)(6) 2017.A patient specific implant request form was received for the patient's distal femur/ proximal tibia replacements indicate a prior revision on (b)(6) 2017.As noted on the form: "he had a washout (b)(6) 2017 with just change out of the bumper, bushings, tibial sleeve and ptr and infection free since then.".
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The following devices were also listed in this report: cat# 64952105; gmrs small femoral bushing; lot# unknown.Cat# 64812130; mrhk bumper insert - neutral; lot# unknown.Cat# 64812140; mrhk tibial sleeve; lot# unknown.Cat# 64953101; gmrs proximal tib sml; lot# unknown.Cat# 64853111; mrs fem stem w/o body 11x127mm; lot# unknown.Cat# 64956050; gmrs extension piece 50mm; lot# unknown.Cat# 64956060; gmrs extension piece 60mm; lot# unknown.Cat# 64953601; gmrs tib rotating sml comp; lot# unknown.Cat# 64952115; gmrs small axle; lot# unknown.Cat# 64952020; gmrs dist fem comp sml r 65mm; lot# unknown.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 10MM
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15984813
• Report Number: 0002249697-2022-01827
• Device Sequence Number: 20385693
• Product Code: KRO
• UDI-Device Identifier: 07613327048810
• UDI-Public: 07613327048810
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K023087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/15/2022

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 Model Number: 6495-3-010
• Device Catalogue Number: 64953010
• 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: 11/27/2022
• Initial Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 19 YR
• Patient Sex: Male
• Patient Weight: 74 KG