MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 20MM XS/S S1/S2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64813220
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	05/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other 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 knee fem s rgt; cat#64811111; lot#ejs8d; dcon p-fit stem cocr 12mmx80mm; cat#64786397; lot#ah68d; mrh tibial b/plt keel sml 2; cat#64813111; lot#e6p3p; mrh tib rot comp xs-xl; cat#64812100; lot#144649; dcon p-fit stem cocr 16mmx80mm; cat#64786405; lot#cd32s1; mrhk fem distal blk 10mm s; cat#64811210; lot#bar2d; mrhk bumper insert 3 degrees; cat#64812133; lot#lhr193; mrhk fem distal blk 10mm s; cat#64811210; lot#bar2d; mrh axle; cat#64812120; lot#ctd32331; mrhk femoral bushing; cat#64812110; lot#lhb466; mrhk tibial sleeve; cat#64812140; lot#lhs015; mrhk femoral bushing; cat#64812110; lot#lhj553.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not available.
Event or Problem Description
Right knee revision due to possible infection.The surgeon did not confirm whether or not this was the case at the time of surgery.

• Brand Name: MRHK TIB INS 20MM 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: 8730473
• Report Number: 0002249697-2019-02368
• Device Sequence Number: 2573136
• Product Code: KRO
• UDI-Device Identifier: 07613327043839
• UDI-Public: 07613327043839
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/25/2019

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: 02/28/2023
• Device Catalogue Number: 64813220
• Device Lot Number: LHH683
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 06/25/2019
• 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 Weight: 85