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 Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/04/2019
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.Device not available.
Event or Problem Description
It was reported that the exeter stem fractured distally and was revised.
Additional Manufacturer Narrative
An event 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: visual inspection was performed as part of the material analysis report (mar), dated 17 september 2019.This inspection indicated: the stem fractured approximately 3.1 inches from the distal tip.Damage was observed on the stem consistent with the cement-mantle breakdown process in addition to the explantation process.The distal fracture surface was obscured by post fracture abrasion, no further analysis was performed.Macroscopic surface features on the proximal fracture surface indicate that the fracture initiated on the posterior side of the lateral surface and propagated medially.A material analysis has been performed.The report concluded: the stem fractured in fatigue with the final fracture occurring in overload.Eds showed the stem was consistent with an 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 records by a clinical consultant stated the following comment: x-ray confirms fractured stem, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays 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.Visual inspection was performed as part of the material analysis report (mar), dated 17 september 2019.This inspection indicated: the stem fractured approximately 3.1 inches from the distal tip.Damage was observed on the stem consistent with the cement-mantle breakdown process in addition to the explantation process.The distal fracture surface was obscured by post fracture abrasion, no further analysis was performed.Macroscopic surface features on the proximal fracture surface indicate that the fracture initiated on the posterior side of the lateral surface and propagated medially.A material analysis has been performed.The report concluded: the stem fractured in fatigue with the final fracture occurring in overload.Eds showed the stem was consistent with an 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 confirmed as insufficient information was provided.Further information such as primary and revision operative reports, clinical and past medical history and additional serial dated x-rays are required to complete the investigation for determining 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
It was reported that the exeter stem fractured distally and was revised.

• 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: 8840904
• Report Number: 0002249697-2019-02721
• Device Sequence Number: 18916041
• Product Code: JDI
• UDI-Device Identifier: 04546540509048
• UDI-Public: 04546540509048
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/24/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 0580-1-044
• Device Lot Number: G3580754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Initial Date Received by Manufacturer: 07/04/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 10/24/2019
• 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 Age: 68 YR
• Patient Weight: 111