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 Codes	Degraded (1153); Fracture (1260)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544)
Date of Event	01/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "a patient that had a left primary direct anterior hip replacement on (b)(6) 2023.Over 15 months later he reported pain and limited range of motion and subsequently followed up with dr., dr.Saw on x-ray that there were what looked to be fractured pieces of the patients biolox delta v40 femoral head.The patient was then brought to surgery for a head and liner exchange revision surgery.Intraoperatively: the surgeon noticed fragmented pieces of the biolox delta v40 and the femoral head was split in half.There were some dark staining of the soft tissues and a slight metallosis appearance.The surgeon removed the femoral head, remaining ceramic pieces in the joint, as well as the liner, the stem and cup were well fixed, not damaged, and then retained.The surgeon then put a v40 to c- taper adaptor sleeve on and a new biolox c-taper femoral head." rep reported that the (consultant) surgeon would like investigation results, and that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, 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 relevant reported discrepancies.There have been no other similar events for the lot referenced.
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 image depicted shows the bearing surface of the returned pieces of the v40 femoral head.The fracture surface of the returned pieces.On visual examination, fracture of the femoral head was observed with two large pieces, seven 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.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: "the ap tha x-ray shows a press fit tha in anatomic position.However, it also demonstrates "fracture" and fragmentation of the ceramic femoral head.Fracture of a tha femoral head is confirmed.The root cause of this mechanical complication can not de determined from the documentation provided." 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.A review of the provided medical records by a clinical consultant stated the following comment: "the ap tha x-ray shows a press fit tha in anatomic position.However, it also demonstrates "fracture" and fragmentation of the ceramic femoral head.Fracture of a tha femoral head is confirmed.The root cause of this mechanical complication can not de determined from the documentation provided." visual inspection & material analysis :the image depicted shows the bearing surface of the returned pieces of the v40 femoral head.The fracture surface of the returned pieces.On visual examination, fracture of the femoral head was observed with two large pieces, seven 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.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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21442539
• Report Number: 0002249697-2025-00223
• Device Sequence Number: 14584717
• Product Code: LZO
• UDI-Device Identifier: 04546540608543
• UDI-Public: 04546540608543
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K052718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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: 10303752
• 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: 01/27/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 02/23/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2023
• 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: 64 YR
• Patient Sex: Male