MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 33MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	0580-1-330
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/13/2019
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.
Event or Problem Description
Pain complained on the left foot (affected leg), so visited to the hospital.It has both legs tha on (b)(6) 2012 and this time the left foot stem is broken.Removed the stem, inserted the same size stem and reduced, but possibility intended to dislocate, so remove the cup.The cup is compatible with the rimfit cup.Implanted stem 33 + 4 head 54 mm rimfit replaced.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a exeter stem was reported.The event was confirmed by material analysis.-product evaluation and results: visual inspection of the returned device noted the following: the distal section of the returned hip stem is approximately 3.02in long from tip to fracture surface.Damage consistent with explantation is present on the distal section of the implant.The explantation damage obscured the fracture surface; no further visual analysis was performed.Macroscopic surface features on proximal fracture surface indicate the fracture initiated on the lateral surface, propagated medially, and terminated at the medial surface.The proximal fracture surface was analyzed further using a scanning electron microscope sem.Material analysis of the returned device noted the following: the stem fractured in fatigue with the final fracture occurring in overload.Damage was observed near the location of fracture origin, consistent with contact against a hard object.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: no medical records were received for review with a clinical consultant.-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.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Pain complained on the left foot (affected leg), so visited to the hospital.It has both legs tha on 2012/4/11 and this time the left foot stem is broken.Removed the stem, inserted the same size stem and reduced, but possibility intended to dislocate, so remove the cup.The cup is compatible with the rimfit cup.Implanted stem 33 + 4 head 54 mm rimfit replaced.

• Brand Name: EXETER V40 STEM 33MM
• 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: 8386983
• Report Number: 0002249697-2019-01247
• Device Sequence Number: 2051915
• Product Code: JDI
• UDI-Device Identifier: 04546540153227
• UDI-Public: 04546540153227
• Combination Product (Y/N): N
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 05/29/2019

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: 01/31/2017
• Device Catalogue Number: 0580-1-330
• Device Lot Number: G3206076
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 05/29/2019
• 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: 120