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	Ambulation or Postural Difficulties (2544)
Date of Event	08/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.
Event or Problem Description
Exeter stem trunnion breakage - patient walking at work and instantly collapsed.Patient presented to hospital.Reported by registrar/surgeon to territory manager.Revision surgery on (b)(6) 2022.No signs of metalosis in tissues upon revision.(initial procedure on (b)(6) 2016) right side.
Additional Manufacturer Narrative
An event regarding crack/fracture involving an exeter stem was reported.The event was confirmed via evaluation of device photos and clinician review of the provided medical records.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.Visual inspection of the photographs of the device indicated that 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 consistent with fatigue fracture advancement occurring until the stem fractured from stress overload.-clinician review: a review of the provided medical information by a clinical consultant indicated: "unlabeled/undated: ap hip x-ray right.Well cemented exeter style stem and well-fixed cup.The stem is fractured at the base of the trunnion/neck at the junction to the body.The construct is failed in varus.Narrative: no history was provided other than the patient collapsed.There was an unlabeled and undated right hip x-ray that showed a broken exeter style stem.Conclusion/assessment: an exeter style stem fractured at the base of the neck at the junction to the body of the stem.Event confirmation: a stem fracture and failure can be confirmed from the x-ray.The patient and date cannot be confirmed.Root cause: a root cause cannot be ascertained without additional medical information.-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 of the photographs of the device indicated that 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 consistent with fatigue fracture advancement occurring until the stem fractured from stress overload.The event was further confirmed through clinician review of the provided x-ray image.A root cause could not be determined from the information provided.It is possible that the reported patient trauma (fall) contributed to the device failure.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Exeter stem trunnion breakage - patient walking at work and instantly collapsed.Patient presented to hospital.Reported by registrar/surgeon to territory manager.Revision surgery on (b)(6) 2022.No signs of metalosis in tissues upon revision.(initial procedure on (b)(6) 2016) right side.

• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15462528
• Report Number: 0002249697-2022-01391
• Device Sequence Number: 17832111
• Product Code: JDI
• UDI-Device Identifier: 04546540153241
• UDI-Public: 04546540153241
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2023

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: 01/31/2021
• Device Model Number: 0580-1-352
• Device Catalogue Number: 0580-1-352
• Device Lot Number: G5879268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/30/2022
• Supplement Date Received by Manufacturer: 02/11/2023
• Initial Report FDA Received Date: 09/22/2022
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2016
• 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: 66 YR
• Patient Sex: Female