MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 16MM XS/S S1/S2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6481-3-216
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Ambulation or Postural Difficulties (2544)
Date of Event	06/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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.The following devices were also listed in this report: mrhk bumper insert 3 degrees; cat# 64812133 ; lot# lks653; gmrs small femoral bushing; cat# 64952105 ; lot# lkx144; gmrs small femoral bushing; cat# 64952105; lot# lkx144; gmrs small axle; cat# 64952115; lot# ctd59683; mrh tib rot comp xs-xl; cat# 64812100; lot#180755; gmrs dist fem comp sml l 65mm; cat# 64952010; lot#j4h2r; mrhk tibial sleeve; cat# 64812140; lot# lks093.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Dr.Performed an above the knee amputation, left side of a patient that had a gmrs distal femoral replacement in due to infection.The previous surgery was on (b)(6) 2022 for an infection, however the knee became infected again.

• Brand Name: MRHK TIB INS 16MM XS/S S1/S2
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 14951890
• Report Number: 0002249697-2022-00982
• Device Sequence Number: 17491684
• Product Code: KRO
• UDI-Device Identifier: 07613327043808
• UDI-Public: 07613327043808
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K994207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/07/2022

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: 6481-3-216
• Device Catalogue Number: 64813216
• Device Lot Number: LLC740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female