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 Codes	Fall (1848); Ambulation or Postural Difficulties (2544)
Date of Event	07/16/2025
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 relevant reported discrepancies.There have been no other similar events for the lot referenced.
Event or Problem Description
Left thr done in 2021.Patient presented to emergency department after recent fall from bicycle.Ceramic femoral head dislodged from femoral stem.Revision hip surgery required to remove fractured ceramic femoral head and replace head, stem and acetabular insert.
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 inspection of the returned device.Method & results: product evaluation and results: visual inspection & material analysis: the images show the returned pieces of the v40 ceramic femoral head.Image shows an overview image of the returned exeter femoral stem.On visual examination, fracture of the femoral head was observed with two large pieces and two 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.Stereo microscope images show areas of surface material damage which were observed on all sides of the stem trunnion.Significant surface material damage was observed around the neck area of the posterior side of the stem, as shown image, attributed to explantation damage.Image shows a stereo microscope image of mechanical damage observed in the mid-stem region.These indications are likely a result of third-body damage and micromotion effects due to cement mantle breakdown.Review of delta v40 femoral head, catalogue # 6570-0-736, lot code 77745301 and exeter femoral stem, catalogue # 0580-1-501, lot code g8030600 confirmed fracture of the femoral head.Characterization 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 product history records indicate the reported device was manufactured with no reported relevant 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.The images show the returned pieces of the v40 ceramic femoral head.Image shows an overview image of the returned exeter femoral stem.On visual examination, fracture of the femoral head was observed with two large pieces and two 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.Stereo microscope images show areas of surface material damage which were observed on all sides of the stem trunnion.Significant surface material damage was observed around the neck area of the posterior side of the stem, as shown image, attributed to explantation damage.Image shows a stereo microscope image of mechanical damage observed in the mid-stem region.These indications are likely a result of third-body damage and micromotion effects due to cement mantle breakdown.Review of delta v40 femoral head, catalogue # 6570-0-736, lot code 77745301 and exeter femoral stem, catalogue # 0580-1-501, lot code g8030600 confirmed fracture of the femoral head.Characterization 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.

• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22795557
• Report Number: 0002249697-2025-00870
• Device Sequence Number: 18303594
• Product Code: LZO
• UDI-Device Identifier: 04546540608581
• UDI-Public: 04546540608581
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K052718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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 Expiration Date: 02/28/2025
• Device Catalogue Number: 6570-0-736
• Device Lot Number: 77745301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 11/22/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2020
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 100 KG