MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 10MM M/L M2/L2; KNEE JOINT FEMOROTIBIAL METAL/POLYMER CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number	64813310
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	06/19/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices listed in this event: catalog: 64812100, description: mrh tib rot comp xs-x,l lot: 038377; catalog: 64812120, description: mrh axle lim rev, lot: ctd2117; catalog: 64812110, description: mrhk femoral bushing, lot: ldf733; catalog: 64812130, description: mrhk bumper insert - neutral, lot: ldf257; catalog: 64812140, description: mrhk tibial sleeve, lot: lcz994; catalog: 5565-s-014, description: tri press-fit stem 14mm x 100mm, lot: m6v07j; catalog: 64952040, description: gmrs dist fem comp std r 65mm, lot: s98ej; catalog: 64853113, description: mrs fem stem w/o body 13x127mm, lot: 115023a.At this time, it cannot be determined which, if any of the reported devices may have caused or contributed to the patient's experience.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available for return.
Event or Problem Description
Postoperative diagnosis: patient underwent right total knee replacement & previous revision outside of cors scope.Patient had failed right total knee arthroplasty secondary to ppfx, underwent the revision of total right knee with treatment of supracondylar femur fracture on (b)(6) 2013 with a dfr by dr.(b)(6).Patient had infected prosthesis right total knee replacement and subtotal synovectomy exchanged (b)(6) 2013.All components exchanged except femur.

• Brand Name: MRHK TIB INS 10MM M/L M2/L2
• Common Device Name: KNEE JOINT FEMOROTIBIAL METAL/POLYMER CONSTRAINED CEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8362541
• Report Number: 0002249697-2019-01166
• Device Sequence Number: 19409992
• Product Code: KRO
• UDI-Device Identifier: 07613327043822
• UDI-Public: 07613327043822
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K994207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2019

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: 05/30/2016
• Device Catalogue Number: 64813310
• Device Lot Number: LCJ706
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 02/22/2019
• 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: 64 YR
• Patient Weight: 66