MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 28/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6570-0-128
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
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
A patient with a bha on (b)(6) 2025.On (b)(6) 2025, it was discovered that the delta ceramic head was partially damaged.The physician plans to follow-up at this time.Other than the damaged implants, there have been no patient symptoms or other health problems to date.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a ceramic head was reported.The event was confirmed via clinician review of provided medical records.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: a review of the provided medical records by a clinical consultant indicated: i have reviewed the documentation provided, including the product inquiry cover sheet, an event summary sheet, an ap pelvis x-ray and a highly magnified x-ray of the tha articulation.Event description: a patient with a bha on (b)(6) 2025.On (b)(6) 2025, it was discovered that the delta ceramic head was partially damaged.The physician plans to follow-up at this time, but contacted stryker wanting to know why it broke.The event summary sheet confirms that a delta v-40 head was implanted.The ap x-ray as well as the magnified x-ray demonstrate a small foreign body alleged to be a chip of the ceramic head.A foreign body within the replaced hip joint is confirmed.No documentation was provided to ascertain the exact material that is constituted in this foreign body was provided.The root cause of this mechanical complication is not able to be determined from the limited information provided.Should further documentation become available i would be happy to further this investigation.-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: as reported: "a patient with a bha on (b)(6) 2025.On (b)(6) 2025, it was discovered that the delta ceramic head was partially damaged.The physician plans to follow-up at this time, but contacted stryker wanting to know why it broke.' a review of the provided medical records by a clinical consultant indicated: the event summary sheet confirms that a delta v-40 head was implanted.The ap x-ray as well as the magnified x-ray demonstrate a small foreign body alleged to be a chip of the ceramic head.A foreign body within the replaced hip joint is confirmed.No documentation was provided to ascertain the exact material that is constituted in this foreign body was provided.The root cause of this mechanical complication is not able to be determined from the limited information provided.Should further documentation become available i would be happy to further this investigation.No further investigation for this event is possible at this time.If device/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 28/0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22305471
• Report Number: 0002249697-2025-00627
• Device Sequence Number: 8621567
• Product Code: JDI
• UDI-Device Identifier: 04546540608499
• UDI-Public: 04546540608499
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2025

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: 6570-0-128
• Device Lot Number: 18576151
• 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: 05/29/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2024
• 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: Other
• Patient Sex: Unknown