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 Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	04/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.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
The patient was relatively high in activity the week of the incident per surgeon.Patient heard a pop on monday on (b)(6).Then, per surgeon, the patient was standing up from the toilet and heard a second pop on the date on (b)(6).The patient then presented to the ed with the femoral head disassociated from the femoral stem on the date on (b)(6).(on xray fracture of the ceramic femoral head was not evident).The revision surgery took place on the following day, on (b)(6) 2025.In the revision surgery, the ceramic femoral head was found to be fractured into 2 large fragments and many smaller fragments.The 2 large fragments were caused by a midline split of the femoral head.The trunnion of the femoral stem was in relatively decent shape, per surgeon.The femoral head and acetabular insert were then revised to a 40 universal femoral head with a +4 v40 taper sleeve and 40e acetabular insert.
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 three 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.Show stereo microscope images of the proximal and distal surfaces of the trident insert.From visual inspection, yellow discolouration consistent with oxidation, possibly a result of synovial fluid absorption, was observed [1].Shows an area with explantation damage on the proximal surface of the insert as highlighted by an arrow.Shows areas of the insert with burnishing, scratching, third body indentations and embedded debris.Burnishing is caused by adhesive/abrasive wear of the insert against the femoral component.Scratching and indentations are caused by third body debris trapped between the insert and femoral component during articulating.Burnishing, scratching, third body indentations and embedded debris are consistent with commonly identified damage modes in uhmwpe inserts [2].-clinician review: a review with a clinical consultant indicated "confirmation of event: i can confirm that the patient underwent both the primary and revision hip arthroplasties because i was able to review the operation reports and i was able to see pre-revision x-rays of the right hip.I did not receive x-rays showing the revision.I can confirm the operative findings since they were contained in the operation report.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of head, neck disassociation with ceramic head fracture are multifactorial, including surgical technique in the positioning and placement of the implants, preparation of the femoral head and trunnion prior to insertion, patient factors including lifestyle, activity level, and bmi, as well as implant factors." -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.Review of delta v40 femoral head, catalogue # 6570-0-736, lot code 20379251 and trident x3 insert, catalogue # 723-00-36e, lot code ax7e3y confirmed fracture.Characterisation using stereo microscopy confirmed the femoral head fractured in overload.A review of medical records indicated "the root cause of this event cannot be determined with certainty.The causes of head, neck disassociation with ceramic head fracture are multifactorial, including surgical technique in the positioning and placement of the implants, preparation of the femoral head and trunnion prior to insertion, patient factors including lifestyle, activity level, and bmi, as well as implant factors." 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/+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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22048659
• Report Number: 0002249697-2025-00523
• Device Sequence Number: 8899062
• Product Code: LZO
• UDI-Device Identifier: 04546540608581
• UDI-Public: 04546540608581
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K233498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,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: 6570-0-736
• Device Lot Number: 20379251
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2024
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 117 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native