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

Catalog Number	6570-0-236
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	04/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The femoral head split while inside of a patient.Revision was successful and completed to my knowledge.
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 similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a ceramic head was reported.The event was confirmed via inspection of the returned device.Method & results: product evaluation and results: visual inspection & material analysis: the images depicted shows the returned trident x3 insert and pieces of the v40 ceramic femoral head.On visual examination, fracture of the femoral head was observed with two large pieces and ten small pieces returned.The pieces showed a generally longitudinal fracture pattern.This type of pattern is created by hoop stress through the wedge effect of the stem trunnion.Shows an overview image of the bearing surface of the v40 femoral head and x3 trident insert.Review of delta v40 femoral head, catalogue # 6570-0-236, lot code 11867651 confirmed fracture.Characterisation using stereo microscopy confirmed the femoral head fractured in overload.No manufacturing or material related defects were observed on the device surfaces examined.Clinician review: no medical records were received for review with a clinical consultant.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 fractured ceramic head.Visual inspection & material analysis: the images depicted shows the returned trident x3 insert and pieces of the v40 ceramic femoral head.On visual examination, fracture of the femoral head was observed with two large pieces and ten small pieces returned.The pieces showed a generally longitudinal fracture pattern.This type of pattern is created by hoop stress through the wedge effect of the stem trunnion.Shows an overview image of the bearing surface of the v40 femoral head and x3 trident insert.Review of delta v40 femoral head, catalogue # 6570-0-236, lot code 11867651 confirmed fracture.Characterisation using stereo microscopy confirmed the femoral head fractured in overload.No manufacturing or material related defects were observed on the device surfaces examined.No further investigation for this event is possible at this time.If additional information becomes 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/+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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22105649
• Report Number: 0002249697-2025-00563
• Device Sequence Number: 20891199
• Product Code: LZO
• UDI-Device Identifier: 04546540608543
• UDI-Public: 04546540608543
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/18/2025

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: 6570-0-236
• Device Lot Number: 11867651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown