MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 0; EXETER 44 00 STEM

Catalog Number	0580-1-440
Medical Device Problem Codes	Break (1069); Crack (1135); Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.
Event or Problem Description
An exeter 44 #00 cement in cement revision stem has fractured within the cement mantle approx 4 year¿s after revision surgery.There was no prior fall or trauma.
Event or Problem Description
An exeter 44 #00 cement in cement revision stem has fractured within the cement mantle approx 4 year¿s after revision surgery.There was no prior fall or trauma.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a exeter stem was reported.Analysis of the returned device confirmed the event.Method & results: product evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 14 january, 2019.This inspection indicated: the parts were examined with the aid of a stereo microscope at magnifications up to 50x.The stem fractured approximately 50 millimeters from the distal tip.The hip stem was assumed to be for the right hip.If subsequent information indicates the stem is for the left hip, the anterior and posterior surfaces of reversed.Damage consistent with the explantation process were observed.Based on macroscopic features, the approximate direction of fracture propagation.The fracture propagated approximately from the lateral to the medial surface.Material analysis of the returned device noted the following: the stem fracture in fatigue, with the fracture propagating from the lateral surface to the medial surface of the stem.Eds showed the stem was consistent with astm f1586 alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: rejected for medical review - x-ray confirms fracture of stem, need operative reports, clinical/past medical history and examination of explanted components.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: medical review confirmed fracture of stem and stated that operative reports, clinical/past medical history and examination of explanted components were required to determine a root cause.Explanted components were returned and material analysis concluded the following: the stem fracture in fatigue, with the fracture propagating from the lateral surface to the medial surface of the stem.Eds showed the stem was consistent with astm f1586 alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined because insufficient information was provided.Further information such operative reports and clinical/past medical history are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: EXETER V40 STEM 44MM NO 0
• Common Device Name: EXETER 44 00 STEM
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7981397
• Report Number: 0002249697-2018-03436
• Device Sequence Number: 13795135
• Product Code: JDI
• UDI-Device Identifier: 04546540509048
• UDI-Public: 04546540509048
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2019

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: 04/30/2015
• Device Catalogue Number: 0580-1-440
• Device Lot Number: G2984769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2018
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 04/01/2019
• 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: 57