MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HMRS AXIS PIN; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	63669220
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received will be provided in a supplemental report.A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.Not returned.
Event or Problem Description
A case of a patient affected by osteosarcoma of the right femur was reported.On 1989 the patient underwent a prosthetic implant.On 2002 and 2004 the femoral stem was revised.On (b)(6) 2017, following a traumatic event, the patient showed the breakage of the axle fixed hinged knee.

• Brand Name: HMRS AXIS PIN
• 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: 7609050
• Report Number: 0002249697-2018-01824
• Device Sequence Number: 19210662
• Product Code: KRO
• UDI-Device Identifier: 07613327049930
• UDI-Public: 07613327049930
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K122015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/18/2018

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: 05/30/2007
• Device Catalogue Number: 63669220
• Device Lot Number: LBWLR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 06/18/2018
• 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; Other; Required Intervention
• Patient Age: 41 YR