MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 36/+2,5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	6570-0-536
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Unequal Limb Length (4534)
Date of Event	09/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: it was reported that the patient's right hip was revised because the patient felt her right leg was shorter than the left.A stem, head and liner were revised.Rep confirmed that there were no allegations against the revised liner, and that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Additional Manufacturer Narrative
Reported event: an event regarding limb length discrepancy involving a ceramic head was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.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's right hip was revised because the patient felt her right leg was shorter than the left.A stem, head and liner were revised.Rep confirmed that there were no allegations against the revised liner, and that no further information will be released by the hospital or surgeon.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 additional information become 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/+2,5
• 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: 23166036
• Report Number: 0002249697-2025-01029
• Device Sequence Number: 8991548
• Product Code: LZO
• UDI-Device Identifier: 04546540608574
• UDI-Public: 04546540608574
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K243784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

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: 6570-0-536
• Device Lot Number: 94190302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/10/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2022
• 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: Other; Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 77 KG