MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	0580-1-440
Medical Device Problem Codes	Fracture (1260); Noise, Audible (3273)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	05/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device noted as returned.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.
Event or Problem Description
It was reported that: "patient underwent a total hip arthroplasty in 2011 with the exeter hip system for an arthritic left hip.Patient claims that he heard a pop as he hopped on one leg to put his pants on.He allegedly broke his exeter stem.Stem is being revised using a cement technique 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.Method & results: product evaluation and results: visual inspection indicated surface deformation consistent with micro-motion at the stem-cement interface was observed on the surfaces of the stem.This abrasion is indicative of cyclic stress-strain ultimately leading to fatigue fracture of the stem.Material analysis: not performed as visual inspection provided no indication that the event was a result of a material integrity issue.If further information becomes available additional testing will be performed.-clinician review: a review of medical records with a clinical consultant indicated: "this case concerns a patient who underwent a left total hip arthroplasty in 2011 and then approximately 12 years later sustained a fracture of the femoral stem necessitating revision surgery.I can confirm that the primary hip replacement and the fractured stem took place since i was able to see supporting x-rays.I cannot confirm that the revision took place since i have no supporting documentation such as office notes, operation report or post revision x-ray.The root cause of this event cannot be determined with certainty.The causes of femoral stem fracture which has been cemented for over 12 years is multifactorial.These include surgical technique factors, especially cement technique, patient factors including activity level and bmi, and implant factors." product history review: review of the device history records indicate 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 lot referenced.Conclusions: the patient was revised due to stem fracture.A review of medical records with a clinical consultant indicated: "this case concerns a patient who underwent a left total hip arthroplasty in 2011 and then approximately 12 years later sustained a fracture of the femoral stem necessitating revision surgery.I can confirm that the primary hip replacement and the fractured stem took place since i was able to see supporting x-rays.I cannot confirm that the revision took place since i have no supporting documentation such as office notes, operation report or post revision x-ray.The root cause of this event cannot be determined with certainty.The causes of femoral stem fracture which has been cemented for over 12 years is multifactorial.These include surgical technique factors, especially cement technique, patient factors including activity level and bmi, and implant factors." visual inspection indicated surface deformation consistent with micro-motion at the stem-cement interface was observed on the surfaces of the stem.This abrasion is indicative of cyclic stress-strain ultimately leading to fatigue fracture of the stem.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes and x-rays are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.
Event or Problem Description
It was reported that: "patient underwent a total hip arthroplasty in 2011 with the exeter hip system for an arthritic left hip.Patient claims that he heard a pop as he hopped on one leg to put his pants on.He allegedly broke his exeter stem.Stem is being revised using a cement technique with a new exeter stem.".

• Brand Name: EXETER V40 STEM 44MM NO 0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17140434
• Report Number: 0002249697-2023-00674
• Device Sequence Number: 1932277
• Product Code: LPH
• UDI-Device Identifier: 04546540153296
• UDI-Public: 04546540153296
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K011623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2023

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: 07/31/2015
• Device Model Number: 0580-1-440
• Device Catalogue Number: 0580-1-440
• Device Lot Number: G3008671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 77 KG