MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	0580-1-441
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	12/27/2019
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 returned.
Event or Problem Description
It was reported that the neck of the exeter stem was broken insitu, therefore the implant was extracted and replaced with a new exeter stem.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a exeter stem was reported.The event was confirmed via product inspection.Method & results -product evaluation and results: visual inspection: visual inspection was performed as part of the material analysis report (mar), dated 24-apr-2020.This inspection indicated "the stem was returned in the fractured condition.Damage consistent with the cement mantle breakdown process was observed on the stem.Damage consistent with explantation was also observed on the stem and fracture surfaces.The fracture surface was obscured by post fracture abrasion as well as explantation damage.The fracture initiated on the superior surface and propagated inferiorly.The distal portion of the stem was analyzed further using a scanning electron microscope." material analysis: material analysis of the returned device noted the following: the returned stem had fractured in fatigue; with the fracture propagating inferiorly and final fracture occurring in overload.Damage consistent with the cement mantle breakdown process was observed on the stem.Xrf showed that the stem and head chemistries were consistent with their respective drawings.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.Conclusions: the investigation concluded that the returned stem had fractured in fatigue; with the fracture propagating inferiorly and final fracture occurring in overload.Damage consistent with the cement mantle breakdown process was observed on the stem.Xrf showed that the stem and head chemistries were consistent with their respective drawings.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the neck of the exeter stem was broken in situ, therefore the implant was extracted and replaced with a new exeter stem.

• Brand Name: EXETER V40 STEM 44MM NO 1
• 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: 9627856
• Report Number: 0002249697-2020-00158
• Device Sequence Number: 2768412
• Product Code: JDI
• UDI-Device Identifier: 04546540153302
• UDI-Public: 04546540153302
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/10/2020

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 Model Number: 0580-1-441
• Device Catalogue Number: 0580-1-441
• Device Lot Number: 3327812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Initial Date Received by Manufacturer: 12/30/2019
• Supplement Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 01/24/2020
• Supplement Report FDA Received Date: 06/10/2020
• 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