MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 32/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	6570-0-132
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was provided: "the ceramic femoral head was implanted by the surgical reg by tapping with a regularly used hammer.With just one tap, the ceramic head shattered into multiple pieces.Biolox delta head applied by surgical spr using correct hammer and impactor.Single strike and head shattered.Swab under trunnion and trunnion had been cleaned after final trial- no obvious trunnion deformity noted at that stage swab appeared to have caught all the fragments.Trunnion of femoral stem scored".Remedial actions taken by healthcare facility: "informed the consultant, who then removed the shattered pieces and the stem.A washout and replaced with a new stem and ceramic head".

• Brand Name: DELTA V-40 CERAMIC HEAD 32/0
• 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: 25315131
• Report Number: 0002249697-2026-00471
• Device Sequence Number: 13294005
• Product Code: LZO
• UDI-Device Identifier: 04546540608505
• UDI-Public: 04546540608505
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K243784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 6570-0-132
• Device Lot Number: G8757656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown