MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 33MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	0580-1-330
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	02/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The stem fracture was found.Revision surgery is not planned yet.
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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.H3 other text : device not returned.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an exeter stem was reported.The event was confirmed via clinician review of the provided medical records.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical information by a clinical consultant indicated: "no clinical history or medical information were provided for review.A plain x-ray with significant artifact which is unlabeled and undated shows what appears to be a fracture of an exeter style stem at the midpoint.No significant conclusions can be made as there is no medical history or other information provided.Event confirmation: a stem fracture can be confirmed.Root cause: the root cause of the fracture cannot be ascertained as there is a paucity of information, medical history, and significant artifact over the x-ray." 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 is planned to be revised due to fracture of the stem.A review of the provided medical information by a clinical consultant indicated the following: "no clinical history or medical information were provided for review.A plain x-ray with significant artifact which is unlabeled and undated shows what appears to be a fracture of an exeter style stem at the midpoint.No significant conclusions can be made as there is no medical history or other information provided.Event confirmation: a stem fracture can be confirmed.Root cause: the root cause of the fracture cannot be ascertained as there is a paucity of information, medical history, and significant artifact over the x-ray." 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 stem fracture was found.Revision surgery is not planned yet.

• Brand Name: EXETER V40 STEM 33MM
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 18986187
• Report Number: 0002249697-2024-00506
• Device Sequence Number: 8204311
• Product Code: JDI
• UDI-Device Identifier: 04546540153227
• UDI-Public: 04546540153227
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2024

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: 05/31/2020
• Device Catalogue Number: 0580-1-330
• Device Lot Number: G5694211
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2015
• 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: Other; Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian