MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 24MM XS/S S1/S2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6481-3-224
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	04/20/2020
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.The following devices were also listed in this report: md.Univ.Cement restrictor w/di; cat # b000-1240: lot # unknown.Md.Univ.Cement restrictor w/di; cat # b000-1240; lot # unknown.Mrhk tibial sleeve; cat # 64812140; lot # lje710.Mrhk femoral bushing; cat # 64812110; lot # ljb111.Mrhk femoral bushing; cat # 64812110; lot # ljc140.Mrh tib rot comp xs-xl; cat # 64812100; lot # 154063.Mrh axle; cat # 64812120; lot # ctd32335.Mrhk bumper insert - neutral; cat # 64812130; lot # lje582.Mrs cvd fem st w/o body 17x127; cat # 64853817; lot # 155770b.Gmrs dist fem comp std l 65mm; cat # 64952030; lot # e9e6e.Triathlonasymconeaugsz c lm/rl; cat # 5549-a-231; lot # a903.Duracon s-2 10mm full wedge; cat # 6630-6-515; lot # but4la.Mrh tibial b/plt keel sml 2; cat # 64813111; lot # hln9y.Ti dur reg fluted stem 15x80mm; cat # 64786625; lot # 0084032.Simplex p full dose 1 pack; cat # 6191-1-001; lot # rjz104.Simplex p full dose 1 pack; cat # 6191-1-001; lot # rjz104.Simplex p full dose 1 pack; cat # 6191-1-001; lot # rba017.Simplex p full dose 1 pack; cat # 6191-1-001; lot # rba017.Simplex p full dose 1 pack; cat # 6191-1-001; lot # rlz202.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
It was reported that the patient's left knee was revised.As reported by rep: "a liner and hinge components removed and replaced for infection.No other information is available per hospital policy.".

• Brand Name: MRHK TIB INS 24MM 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
• MDR Report Key: 10069797
• Report Number: 0002249697-2020-00921
• Device Sequence Number: 2628598
• Product Code: KRO
• UDI-Device Identifier: 07613327043815
• UDI-Public: 07613327043815
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K994207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2020

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: 08/31/2022
• Device Model Number: 6481-3-224
• Device Catalogue Number: 64813224
• Device Lot Number: LGC693
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 86