MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 32/-4; prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous

Catalog Number	6570-0-032
Medical Device Problem Codes	Degraded (1153); Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: it was reported that the patient's left hip was revised due to eccentric poly wear.Intra-operatively, it was reported that the patient had a 32mm ceramic femoral head inside of a 36d liner, despite the usage from the prior procedure documenting that a 36mm femoral head was implanted in the 36d liner.The head and liner were revised to a 36mm femoral head with a 36d liner.Hospital staff wants to speak to someone at stryker regarding the fact that a 32mm femoral was implanted in a 36d liner and surgeon wants investigation results.Rep will provide all available documentation and images available from the hospital and 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 has been similar event(s) for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

• Brand Name: DELTA V-40 CERAMIC HEAD 32/-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 NJ NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 25104146
• Report Number: 0002249697-2026-00381
• Device Sequence Number: 9991056
• Product Code: LZO
• UDI-Device Identifier: 04546540608475
• UDI-Public: 04546540608475
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K052718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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 Expiration Date: 09/30/2026
• Device Catalogue Number: 6570-0-032
• Device Lot Number: 89044501, 89044502, 89044503,
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2021
• 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: 76 YR
• Patient Sex: Female