MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 30MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	0580-1-300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	04/06/2021
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 surgeon reported that he operated hip patient on (b)(6) 2018 with stryker hip system and after follow-up he found stem broken when he did xray on (b)(6) 2021.Now surgeon asking the reason for breakage and support for patient.The implants are not available for return due to still being in the patient.Patient has not been revised as of the time of report.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a exeter stem was reported.The event was confirmed by medical review.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted.Clinician review: a review of the provided medical information by a clinical consultant indicated: event date: (b)(6) 2021, opened (b)(6) 2021.Event description: surgeon reported that he operated hip patient on (b)(6) 2018 with stryker hip system and after follow up he found stem broken when did xray on (b)(6) 2021.Now surgeon asking the reason for breakage and support for patient.Update (b)(6) 2021 wg: the implants are not available for return due to still being in the patient.Patient has not been revised as of the time of report.Implants involved: exeter v40 stem 30mm.Materials reviewed: (b)(6) 2021: two stamp dates: implant sheet.Exeter low profile acetabular cp 52x28mm, exeter v40 cemented stem 30x95mm, v40 femoral head 28 $mm, exeter 2.5mm intramedullary plug x12mm and 10mm.Undated: implant sheet partial photo.Exeter low profile acetabular cup 52 x 28mm, cemented exeter v40 hip stem 30x95mm, exeter low profile acetabular cup 56 x 28mm.On (b)(6) 2020: ap pelvis x-ray.Sides not labeled.Cemented exeter in varus, appears under sized.Well fixed all poly shell.On (b)(6) 2021: ap pelvis x-ray.Left tha.Cemented exeter in varus now with fracture at mid 1/3 of stem some lucency at proximal stem and small cystic lesions.Well fixed all poly shell.On (b)(6) 2018: ¿discharge summary¿.Photo of d/c summary with preoperative x-ray photo and obscured postoperative x-ray.Tha on (b)(6) 2018.35 yo male patient.Bony anatomy with somewhat rotated pelvis and cystic changes in femur.Confirmation: the event a fracture of an exeter stem in situ can be confirmed.Root cause: the root cause cannot be confirmed without additional information.However, the likely cause of failure was proximal loosening and high varus forces on the undersized stem in a young patient.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 exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, 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 devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The surgeon reported that he operated hip patient on (b)(6) 2018 with stryker hip system and after follow-up he found stem broken when he did xray on (b)(6) 2021.Now surgeon asking the reason for breakage and support for patient.The implants are not available for return due to still being in the patient.Patient has not been revised as of the time of report.

• Brand Name: EXETER V40 STEM 30MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 11854016
• Report Number: 0002249697-2021-00885
• Device Sequence Number: 14457291
• Product Code: JDI
• UDI-Device Identifier: 04546540153210
• UDI-Public: 04546540153210
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2022

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: 0580-1-300
• Device Catalogue Number: 0580-1-300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Male