MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40(TM). SHORT FEMORAL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	0580-1-044
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Patient who treated bha in 2012 (other company implant) was infected and revised in exeter for the first time in 2012.Confirming breakage of the stem by follow up on (b)(6) 2018.Next year in 2019 we will remove the broken stem and it will be replaced again.(b)(6) 2018 - stem broke in the middle.

• Brand Name: EXETER V40(TM). SHORT FEMORAL
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8209446
• Report Number: 0002249697-2019-00005
• Device Sequence Number: 10812282
• Product Code: JDI
• UDI-Device Identifier: 04546540509048
• UDI-Public: 04546540509048
• Combination Product (Y/N): N
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/02/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0580-1-044
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 01/02/2019
• 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: Other