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

Catalog Number 0580-1-300

Device Problem Fracture (1260)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Pain (1994)

Event Date 12/15/2023

Event Type  Injury  

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.Device not returned.

Event Description

The following was reported: primary surgery date is (b)(6) 2022.In (b)(6) 2023, the patient fell but had no problem walking, but on (b)(6) 2023, the patient came the hospital with pain in the right hip.Revision surgery was performed on december 15, 2023 for a suspected peri-stem fracture, and the stem was also found to be broken.

Event Description

The following was reported: primary surgery date is (b)(6) 2022.In (b)(6) 2023, the patient fell, but had no problem walking.But, on (b)(6) 2023.The patient came the hospital with pain in the right hip.Revision surgery was performed on (b)(6) 2023, for a suspected peri-stem fracture.And the stem was also, found to be broken.

Manufacturer Narrative

Reported event: an event, regarding crack/fracture involving an exeter stem was reported.The event, of crack/fracture was confirmed.Periprosthetic fracture was not confirmed.Method & results: product evaluation and results: material analysis, review of exeter v40 stem 30mm, catalogue #: 0580-1-300, lot code#: g7279091.Confirmed, fracture of the stem.Characterisation using stereo microscopy and scanning electron microscopy confirmed, fracture of the stem through the mid-stem region.The fracture was observed, to have propagated in fatigue with final fracture in overload.No manufacturing or material related defects were observed, on the device surfaces examined.Clinician review: a review of the provided medical records, by a clinical consultant indicated, the x-ray as well as, the multiple photographs provided.Confirm, a fracture of a total hip stem.The fracture is transverse and located in the upper portion of the stem.The root cause of this mechanical failure cannot be determined, from the limited documentation provided.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.Material analysis, review of exeter v40 stem 30mm, catalogue#: 0580-1-300, lot code#: g7279091.Confirmed, fracture of the stem.Characterisation using stereo microscopy and scanning electron microscopy confirmed, fracture of the stem through the mid-stem region.The fracture was observed, to have propagated in fatigue with final fracture in overload.No manufacturing or material related defects were observed, on the device surfaces examined.A review of the provided medical records, by a clinical consultant indicated, the x-ray as well as, the multiple photographs provided.Confirm, a fracture of a total hip stem.The fracture is transverse and located in the upper portion of the stem.The root cause of this mechanical failure cannot be determined, from the limited documentation provided.

• Brand Name: EXETER V40 STEM 30MM
• Type of Device: 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: 18468677
• MDR Text Key: 332375504
• Report Number: 0002249697-2024-00048
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 04546540153210
• UDI-Public: 04546540153210
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 0580-1-300
• Device Lot Number: G7279091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian