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

Model Number	0580-1-044
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Injury (2348); Insufficient Information (4580)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
The surgeon revised the patient's total hip prosthesis due to the break of the exeter nail implanted in the patient.
Event or Problem Description
The surgeon revised the patient's total hip prosthesis due to the break of the exeter nail implanted in the patient.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an exeter stem was reported.The event was confirmed by clinician review and analysis of returned device.Method & results: product evaluation and results: visual inspection was performed as part of the material analysis report (mar), which indicated: the stem was returned in the fractured condition.The stem was examined with the aid of a stereo microscope at magnifications up to 50x.Damage consistent with the explantation process was observed on the lateral surface of the stem.Plastic surface deformation consistent with micro-motion at the stem-cement interface was observed on the medial surface of the stem.Macroscopic surface features indicate that the fracture initiated on the lateral surface and propagated medially.Damage consistent with the explantation process and/or post fracture abrasion was observed on the proximal and distal fracture surfaces of the stem.The distal fracture surface was examined further using a scanning electron microscope (sem).A material analysis has been performed.The report concluded: plastic surface deformation consistent with micro-motion at the stem-cement interface was observed on the medial surface of the stem.The fracture morphology was consistent with a fatigue fracture.Damage consistent with the explantation process and/or post fracture abrasion was observed on the proximal and distal fracture surfaces of the stem.Eds analysis showed that the stem is consistent with the drawing (an astm f1586 alloy).Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined for the devices with catalog numbers provided.Dimensional & functional analysis were not performed as device was returned in fractured condition.Clinician review: the available medical records were provided to the consulting clinician for a review which concluded that the fracture of the exeter stem was confirmed as was the revision surgery.The stem was likely "potted in the cement" (the distal portion was found well fixed and the proximal portion loose at revision) leading to fatigue failure from micromotion.Obtaining the implant may provided insight into the mechanism of failure.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: it was reported that patient had a revision due to fracture of the exeter stem.The available medical records were provided to the consulting clinician for a review which concluded that the fracture of the exeter stem was confirmed as was the revision surgery.The stem was likely "potted in the cement" (the distal portion was found well fixed and the proximal portion loose at revision) leading to fatigue failure from micromotion.Obtaining the implant may provided insight into the mechanism of failure.A material analysis has been performed on the returned device.The report concluded: plastic surface deformation consistent with micro-motion at the stem-cement interface was observed on the medial surface of the stem.The fracture morphology was consistent with a fatigue fracture.Damage consistent with the explantation process and/or post fracture abrasion was observed on the proximal and distal fracture surfaces of the stem.Eds analysis showed that the stem is consistent with the drawing (an astm f1586 alloy).Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined for the devices with catalog numbers provided.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.

• 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: 10305527
• Report Number: 0002249697-2020-01517
• Device Sequence Number: 14097612
• Product Code: JDI
• UDI-Device Identifier: 04546540509048
• UDI-Public: 04546540509048
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: 0580-1-044
• Device Catalogue Number: 0580-1-044
• Device Lot Number: G3631968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 11/16/2020
• 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