MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 37.5MM NO 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	0580-1-352
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/11/2022
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
It has been reported "patient operated with cemented bipolar/hemiarthroplasty done in (b)(6) 2015 has come back today with broken neck of the cemented femoral stem.Exeter stem likely as per the surgeon.Broken neck of femoral cemented stem causing hip pain, leading to implant failure and thereby now the patient is been posted for revision thr for explanting the broken stem and revising the femur.Index surgery done in 2015.The stem is likely to be exeter cemented femoral stem system as per the operating surgeon.More details like implant labels, discharge summary and patient details from index surgery have been requested for.".
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an exeter stem was reported.The event was confirmed via evaluation of the provided photographs of the device.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs of the device indicate that the neck of the stem has fractured.Explantation tooling damage is observed on the surfaces of the stem.What appears to be plastic surface deformation is visible on the body of the stem.Return of the device is required to confirm.Clinician review: a review of the provided medical information by a clinical consultant indicated: "(b)(6) 2015: ap left hip x-ray: cemented exeter style hemiarthroplasty.Well-fixed stem with, collared neck.Bipolar style head.(b)(6) 2022: ap left hip x-ray: cemented exeter style hemiarthroplasty.Some lucency around stem with apparent crack in cement mantle at stem tip.Fractured femoral implant neck at body neck junction event confirmation: the event a fractured femoral stem can be confirmed.Root cause: root cause of the fracture cannot be determined without additional information and perhaps examination of the implant.Most likely cause would be metallic fatigue failure due to stress loading of well-fixed stem and cantilever bending." 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 a fractured exeter stem.The reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs of the device indicate that the neck of the stem has fractured.Explantation tooling damage is observed on the surfaces of the stem.What appears to be plastic surface deformation is visible on the body of the stem.Return of the device is required to confirm.The fracture event was further confirmed through clinician review of the provided x-ray images.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
It has been reported "patient operated with cemented bipolar/hemiarthroplasty done in (b)(6) 2015 has come back today with broken neck of the cemented femoral stem.Exeter stem likely as per the surgeon.Broken neck of femoral cemented stem causing hip pain, leading to implant failure and thereby now the patient is been posted for revision thr for explanting the broken stem and revising the femur.Index surgery done in 2015.The stem is likely to be exeter cemented femoral stem system as per the operating surgeon.More details like implant labels, discharge summary and patient details from index surgery have been requested for.".

• Brand Name: EXETER V40 STEM 37.5MM 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: marisol santiago ; 325 corporate drive; centennial park, elstree; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14018060
• Report Number: 0002249697-2022-00475
• Device Sequence Number: 4558398
• Product Code: LPH
• UDI-Device Identifier: 04546540153241
• UDI-Public: 04546540153241
• 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: 2015
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2023

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: 02/29/2020
• Device Model Number: 0580-1-352
• Device Catalogue Number: 0580-1-352
• Device Lot Number: G5633258
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2015
• 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: Unknown