MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 28/+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	6570-0-228
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Dislocation of hip, surgeon has requested the femoral head be checked if it is indeed a +4 head offset.Mdm implants used with exeter trident.The head dislocated (disassociated) from the stem, but also the inner head disengaged from the outer mdm head.
Additional Manufacturer Narrative
Device evaluation is under review.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 disassociation involving a ceramic head was reported.The event was not confirmed.Method & results: -product evaluation and results: the ceramic head was returned for evaluation.Explantation damage observed on the surface of the device.-clinician review: no medical records were received for review with a clinical consultant.-product history review: could not be performed as the lot number is unknown.-complaint history review: could not be performed as the lot number is unknown.Conclusions: it was reported that the patient was revised due to stem and head disassociation, as well as, the head disengaging from the mdm liner.The ceramic head was returned for evaluation.Explantation damage observed on the surface of the device.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Dislocation of hip, surgeon has requested the femoral head be checked if it is indeed a +4 head offset.Mdm implants used with exeter trident.The head dislocated (disassociated) from the stem, but also the inner head disengaged from the outer mdm head.

• Brand Name: DELTA V-40 CERAMIC HEAD 28/+4
• 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: 21839485
• Report Number: 0002249697-2025-00412
• Device Sequence Number: 7963712
• Product Code: LZO
• UDI-Device Identifier: 04546540608529
• UDI-Public: 04546540608529
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2025

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: 6570-0-228
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 04/15/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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