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	06/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.
Event or Problem Description
Broken exeter stem revised using restoration modular components.
Additional Manufacturer Narrative
An even regarding crack/fracture involving an exeter stem was reported.The event was confirmed through clinician review of the provided medical records.Method & results -product evaluation and results: not performed as no product was returned for evaluation.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: x-ray confirms stem fracture, need additional information; primary and revision operative reports, clinical and past medical history and examination of explanted components.-product history review: a review of the device manufacturing records indicate that all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the clinician review of the provided x-ray confirms stem fracture.The exact cause of the event cannot be confirmed as insufficient information was provided.Further information such as primary and revision operative reports, clinical and past medical history and examination of explanted components are required to complete the investigation and determine a root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Broken exeter stem revised using restoration modular components.

• 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: 8795080
• Report Number: 0002249697-2019-02580
• Device Sequence Number: 11272333
• Product Code: JDI
• UDI-Device Identifier: 04546540509048
• UDI-Public: 04546540509048
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2019

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 Expiration Date: 04/30/2013
• Device Catalogue Number: 0580-1-044
• Device Lot Number: G2529774
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 11/12/2019
• 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: 73