MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 13MM XS/S S1/S2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6481-3-213
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	01/01/2020
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: mrh tib rot comp xs-xl; cat # 64812100; lot # 147291, mrhk tibial sleeve; cat # 64812140; lot # ljb103, mrs 15mm x 127mm femoral stem; cat # 64853015; lot # 116241c, mrh tibial b/plt keel sml 2; cat # 64813111; lot # e9d9a, mrh axle; cat # 64812120; lot # ctd36377, mrhk bumper insert 3 degrees; cat # 64812133; lot # leb982, gmrs dist fem comp std r 65mm; cat # 64952040; lot # dee2j, mrhk femoral bushing; cat # 64812110; lot # ljb109, med howmedica bone plug 1pk; cat # 6215-5-011; lot # cppwd04be, triathlon sym cone aug sz c; cat # 5549-a-130; lot # a494k, kmax stem extnr(s,m,l,xl),80mm; cat # 64768260; lot # lcm1289, med howmedica bone plug 1pk; cat # 6215-5-011; lot # cppwd04be, mrhk femoral bushing; cat # 64812110; lot # lja808.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Patient treated for dair.

• Brand Name: MRHK TIB INS 13MM 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: 9917677
• Report Number: 0002249697-2020-00675
• Device Sequence Number: 2377911
• Product Code: KRO
• UDI-Device Identifier: 07613327043792
• UDI-Public: 07613327043792
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K994207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 04/02/2020

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: 08/31/2023
• Device Model Number: 6481-3-213
• Device Catalogue Number: 64813213
• Device Lot Number: LHP658
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 04/02/2020
• 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 Age: 71 YR