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

Catalog Number	64813213
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	12/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: mrh tib rot comp xs-xl; cat#:64812100; lot#:093791.Mrh tibial b/plt keel sml 1; cat#:64813110; lot#: bdl6c.Tri press-fit stem 13x150mm; cat#:5566-s-013; lot#: m8l16h.Mrhk tibial sleeve; cat#:64812140; lot#: lfd690.Mrhk bumper insert 3 degrees; cat#:64812133; lot#: lel817.Triathlon sym cone aug sz b; cat#:5549-a-120; lot#: adj3.Gmrs small femoral bushing; cat#:64952105; lot#: lfd101.Gmrs small axle; cat#:64952115; lot#: ctd7432.Gmrs dist fem comp sml r 65mm; cat#:64952020; lot#: ar86m.Mrs fem stem w/0 body 15x127mm; cat#:64853115; lot#:148637a.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
Patient underwent 2 stage revision for infection, with the 2nd stage (re-implantation) completed (b)(6) 2016.Patient continued to drain, so underwent extensive irrigation and debridement with poly liner and tibial components exchange on (b)(6) 2016.

• 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: 6420551
• Report Number: 0002249697-2017-00968
• Device Sequence Number: 16327632
• Product Code: KRO
• UDI-Device Identifier: 07613327043792
• UDI-Public: (01)07613327043792(11)151021(17)201031(10)LEP821
• 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: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/21/2017

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: 10/31/2020
• Device Catalogue Number: 64813213
• Device Lot Number: LEP821
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2017
• Initial Report FDA Received Date: 03/21/2017
• 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: 60 YR
• Patient Weight: 105