MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 36/+7,5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	6570-0-736
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	11/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
Patient revised due to a biolox 36 head +7.5 fracture.(left side) surgeon took out stem and broken head and revised to restoration modular component and new liner.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a ceramic head was reported.The event was confirmed via medical review.Method & results: -device evaluation and results: the device was not returned; however, a photograph was provided for review.The photograph shows a recently explanted ceramic head, a stem and an liner.The ceramic head appears fractured in multiple pieces.-clinician review: a review of the provided medical records by a clinical consultant indicated: "confirmation of event: i can confirm that the patient had a primary total hip arthroplasty and sustained a fracture of the ceramic femoral head since i was able to see a radiograph of the hip and photographs of the explanted prostheses.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of ceramic femoral head fracture are multifactorial, including possible surgical technique with unrecognized damage to the femoral head upon insertion, patient factors, including activity level, lifestyle, and bmi, as well as the possibility of trauma and implant factors." -device history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.-complaint history review: there have been one other similar event for the reported lot.Conclusion: it was reported that the patient's hip was revised due to fractured ceramic head.A review of the provided medical records by a clinical consultant indicated: "confirmation of event: i can confirm that the patient had a primary total hip arthroplasty and sustained a fracture of the ceramic femoral head since i was able to see a radiograph of the hip and photographs of the explanted prostheses.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of ceramic femoral head fracture are multifactorial, including possible surgical technique with unrecognized damage to the femoral head upon insertion, patient factors, including activity level, lifestyle, and bmi, as well as the possibility of trauma and implant factors." the device was not returned; however, a photograph was provided for review.The photograph shows a recently explanted ceramic head, a stem and an liner.The ceramic head appears fractured in multiple pieces.No further investigation for this event is possible at this time as no devices and/or insufficient information was received.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
No new information.

• Brand Name: DELTA V-40 CERAMIC HEAD 36/+7,5
• 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: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 23657487
• Report Number: 0002249697-2025-01385
• Device Sequence Number: 4823698
• Product Code: LZO
• UDI-Device Identifier: 04546540608581
• UDI-Public: 04546540608581
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K052718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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 Catalogue Number: 6570-0-736
• Device Lot Number: 11865753
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2023
• 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: 53 YR
• Patient Sex: Male