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

Model Number 0580-1-044

Device Problems Fracture (1260); Insufficient Information (3190)

Patient Problems Ossification (1428); Bone Fracture(s) (1870); Injury (2348); Hip Fracture (2349)

Event Date 01/20/2020

Event Type  Injury  

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 returned.

Event Description

The customer reported that the exeter stem was revised.Reason for revision: broken stem with resultant periprosthetic femoral fracture- severe pain and unable to weight bear.

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving exeter stem was reported.The event was confirmed by medical review and inspection of the returned device method & results: -device evaluation and results: visual inspection: visual inspection was performed as part of the material analysis report (mar), dated 11 may 2020.This inspection indicated."the devices were examined with the aid of a stereo microscope at magnifications up to 50x.The head and proximal portion of the stem were returned in the assembled condition.Nothing noteworthy was observed on the returned head.The returned stem was returned in the fractured condition.Damage consistent with the cement mantle breakdown process was observed on the stem.Damage consistent with explantation process was also observed on the stem.The fracture surface was obscured by post fracture abrasion as well as explantation damage.The fracture initiated on the lateral surface and propagated medially.The proximal portion of the stem was analyzed further using a scanning electron microscope." dimensional inspection and functional inspection: not performed as the reported device was implanted and subsequently explanted.The device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Material analysis a material analysis has been performed.The report concluded: "the returned stem had fractured in fatigue; with the fracture propagating medially.Damage consistent with the cement mantle breakdown process was observed on the stem.Xrf showed that the stem and head chemistries were consistent with an astm f1586 alloys.The stem alloy was consistent with its respective drawing, no catalog number was provided for the returned head.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the stem surfaces examined." a review of the provided medical records and/or x-rays by a clinical consultant indicated: "the likely cause of this event was an inevitable fatigue fracture of the stem after cyclic loading at the junction of the fixed and loose segments of the stem.Examination of the explanted stem and its fracture surfaces could confirm this mechanism and rule out factors associated with implant manufacturing or materials as having contributed to this clinical event." -device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: the returned stem had fractured in fatigue; with the fracture propagating medially.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

The customer reported that the exeter stem was revised.**update** reason for revision: broken stem with resultant periprosthetic femoral fracture- severe pain and unable to weight bear.

• Brand Name: EXETER V40(TM). SHORT FEMORAL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9756558
• MDR Text Key: 184424576
• Report Number: 0002249697-2020-00394
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 04546540509048
• UDI-Public: 04546540509048
• Combination Product (y/n): N
• PMA/PMN Number: K173499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

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
• Device Operator: Health Professional
• Device Model Number: 0580-1-044
• Device Catalogue Number: 0580-1-044
• Device Lot Number: G6166211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: 05/22/2020
• Supplement Dates FDA Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 33