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

Catalog Number	0580-1-440
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	07/28/2023
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
The following was reported: revision hip surgery for an exeter stem that's snapped at the neck in situ.
Event or Problem Description
The following was reported: revision hip surgery for an exeter stem that's snapped at the neck in situ.
Additional Manufacturer Narrative
An event regarding crack/fracture involving an 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.Clinician review: no medical records were received for review with a clinical consultant.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: it was reported that the patient was revised due to fracture of the exeter stem.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.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an exeter stem was reported.The event was confirmed via evaluation of the returned device.Method & results: product evaluation and results: material analysis: review of the exeter v40 stem 44mm no 0, catalogue # 0580-1-440, lot code g7720383 confirmed fracture through the prehension hole.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture of the stem through the prehension hole due to fatigue, with final fracture in overload.Surface material damage was observed across the stem surfaces, indicating micromotion effects, due to cement mantle breakdown.No manufacturing or material related defects were observed on the device surfaces examined.Clinician review: a review of the provided medical records by a clinical consultant indicated: the ap undated x-rays show a cemented tha in anatomic position with pristine interfaces.The second ap x-ray shows a similar appearing tha with neck that has fractured near its base and now is grossly displaced into a varus position.The hospital records reflect an uncomplicated cemented exeter tha with anormal postoperative course.The two consultant post-operative notes state the patient was recovering well early on.These records confirm that the patient had a fracture of the stem of his exeter femoral prosthesis.I cannot discern the root cause of this mechanical failure from the limited documentation provided.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: it was reported that the patient was revised due to fracture of the exeter stem.Material analysis: review of the exeter v40 stem 44mm no 0, catalogue # 0580-1-440, lot code g7720383 confirmed fracture through the prehension hole.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture of the stem through the prehension hole due to fatigue, with final fracture in overload.Surface material damage was observed across the stem surfaces, indicating micromotion effects, due to cement mantle breakdown.No manufacturing or material related defects were observed on the device surfaces examined.A review of the provided medical records by a clinical consultant indicated: the ap undated x-rays show a cemented tha in anatomic position with pristine interfaces.The second ap x-ray shows a similar appearing tha with neck that has fractured near its base and now is grossly displaced into a varus position.The hospital records reflect an uncomplicated cemented exeter tha with a normal postoperative course.The two consultant post-operative notes state the patient was recovering well early on.These records confirm that the patient had a fracture of the stem of his exeter femoral prosthesis.I cannot discern the root cause of this mechanical failure from the limited documentation provided.If further information becomes available, this investigation will be re-opened.
Event or Problem Description
The following was reported: revision hip surgery for an exeter stem that's snapped at the neck in situ.Update: revision was required due to snapped stem, surgeon removed implant, required eto to remove broken stem and completed cement on cement revision.Additional information from patient: " i had a hip replacement in on (b)(6) 2020.The joint ¿failed¿ on (b)(6) this year.The consultants at the hospital where i had the hip revision done mentioned that the original hip was made by stryker.I¿m really keen to understand the cause of the failure, there was no trauma, accident or fall involved.What information do i need to provide you with so that you can identify the implant and help me understand the cause of the failure? i¿m in the latter stages of my recovery from the procedure but it¿s been a long haul and i am really keen to avoid any repetition of this failure.Issue occurred "going up the stairs to bed my right leg ¿gave way¿ with no fall or other trauma".

• 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: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 17600522
• Report Number: 0002249697-2023-00919
• Device Sequence Number: 6307567
• Product Code: LPH
• UDI-Device Identifier: 04546540153296
• UDI-Public: 04546540153296
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2024

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: 10/31/2024
• Device Catalogue Number: 0580-1-440
• Device Lot Number: G7720385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2023
• Supplement Date Received by Manufacturer: 01/29/2024; 03/22/2024
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 01/30/2024; 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White