MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 10MM XS/S S1/S2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6481-3-210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/21/2023
Type of Reportable Event	Serious Injury
Additional 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.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.The following devices were also listed in this report: device name#mrhk femoral bushing ; cat#64812110 ; lot#lkl450, device name#mrhk bumper insert - neutral ; cat#64812130 ; lot#lkl766, device name#mrh tib rot comp xs-xl ; cat#64812100 ; lot#172839 device name#mrh axle ; cat#64812120 ; lot#ctd54890, device name#gmrs proximal tibial standard ; cat#64953102 ; lot#178162k, device name#mrhk tibial sleeve ; cat#64812140 ; lot#lkl784, device name#mrh knee fem l lft ; cat#64811130 ; lot#ent6n, device name#17mm press fit fluted stem ; cat#6495-5-017 ; lot#193825e, device name#ti dur reg fluted stem 17x80mm ; cat#64786635 ; lot#0108541, and device name#md.Universal cement restrictor ; cat#b000-0240 ; lot#6m9994.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.H3 other text : device not returned to the manufacturer.
Event or Problem Description
This pi is for the planned revision of the patient's left knee arthrodesis on (b)(6) 2023.Noted on the prescription form: "55-year-old male patient, with infected left proximal tibia endoprosthesis, he received, removal of the implant and serial debridement, and currently on iv antibiotics." "we need to reconstruct the defect with custom made knee endoprosthesis implant, as the patient has limited knee flexion already, and lost a significant portion of his quad strength." update: "(b)(6) 2022 check in the hospital with infected wound, then developed chronic sinus tract infection"."patient has a stiff knee, and decreased range of motion, heavy smoker (2 packs a day)".

• Brand Name: MRHK TIB INS 10MM 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16909302
• Report Number: 0002249697-2023-00499
• Device Sequence Number: 20695870
• Product Code: KRO
• UDI-Device Identifier: 07613327043785
• UDI-Public: 07613327043785
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: K994207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2023

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: 01/31/2026
• Device Model Number: 6481-3-210
• Device Catalogue Number: 64813210
• Device Lot Number: LKN031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2021
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 53 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White