MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA V40-FEMORAL HEAD 32MM, +4MM NK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	6565-0-232
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Fall (1848)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
The following information was provided: the mps reported that: "i am reporting a medical device vigilance case following a mako pth on the left side performed on (b)(6) 2023.After falling out of bed, the patient returned a few days ago and the scan showed that the alumina ceramic head had exploded." "the revision is scheduled for today.We will keep the head and the pieces to send them back to the manufacturer and get feedback on the material analysis.".
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a ceramic head was reported.The event was confirmed via evaluation of the photographs provided.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs show a recently explanted ceramic head fractured into pieces.No other inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records by a clinical consultant indicated: conclusion of assessment reported event of failure is confirmed.The time course would indicate that the fall is a causal factor of implant failure.It is not confirmed that the implant contributed to the fall or that there were proceeding signs of implant failure.Possible procedure related factors that may have contributed to the event include ceramic-on-ceramic articulation.Identified patient risk factors for increased implant failure risk in this patient include male sex.There is no confirmed device related factors identified that contributed to adverse event.-product history review: review of the device history records indicate the 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: the reported device was not returned however photographs were provided for review.The photographs show a recently explanted ceramic head fractured into pieces.A review of the provided medical records by a clinical consultant indicated: conclusion of assessment reported event of failure is confirmed.The time course would indicate that the fall is a causal factor of implant failure.It is not confirmed that the implant contributed to the fall or that there were proceeding signs of implant failure.Possible procedure related factors that may have contributed to the event include ceramic-on-ceramic articulation.Identified patient risk factors for increased implant failure risk in this patient include male sex.There is no confirmed device related factors identified that contributed to adverse event.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: ALUMINA V40-FEMORAL HEAD 32MM, +4MM NK
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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 ; raheen business park; limerick, NJ NA ; EI NA ; +353 2018315000
• MDR Report Key: 24362417
• Report Number: 0002249697-2026-00098
• Device Sequence Number: 20071797
• Product Code: LZO
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K243784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2026

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: 03/31/2024
• Device Catalogue Number: 6565-0-232
• Device Lot Number: 70811301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2019
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 198 LB