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

Model Number	0580-1-352
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/16/2021
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
It was reported that the patient presented with stem fx and pain in the right hip.The xrays showed fx and the patient required a revision surgery to a restoration modular.
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 and clinician review of provided medical records.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device is fractured at the upper proximal third of the stem body.Plastic 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: a review of the provided medical information by a clinical consultant indicated: "this inquiry reports failure of an exeter stem about 6 years after implantation due to femoral stem fracture in a gentleman who weighed 295 pounds.I can confirm that this event took place since i was able to review an x-ray that shows the fracture.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of stem fracture are multifactorial including surgical technique factors, cementing technique factors, implant factors, and patient factors such as weight and activity level." -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 fractured exeter stem.Visual inspection of the returned device indicated that the device is fractured at the upper proximal third of the stem body.Plastic 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.No further investigation for this event is possible 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 patient presented with stem fx and pain in the right hip.The xrays showed fx and the patient required a revision surgery to a restoration modular.

• Brand Name: EXETER V40 STEM 37.5MM NO 0
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12974859
• Report Number: 0002249697-2021-02037
• Device Sequence Number: 17222559
• Product Code: JDI
• UDI-Device Identifier: 04546540153241
• UDI-Public: 04546540153241
• 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 Implanted Year: 2015
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2023

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: 04/30/2020
• Device Model Number: 0580-1-352
• Device Catalogue Number: 0580-1-352
• Device Lot Number: G5667490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2021
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2015
• 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 Age: 49 YR
• Patient Sex: Male
• Patient Weight: 134 KG