MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 36/+7,5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 6570-0-736

Device Problem Fracture (1260)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2023

Event Type  Injury  

Event Description

Biolox v40 plus 7.5 head fractured in half.Original primary hip was done on 2/14/23.Revision performed.

Manufacturer Narrative

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.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.

Event Description

Biolox v40 plus 7.5 head fractured in half.Original primary hip was done on (b)(6) 2023.Revision performed.

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving a ceramic head was reported.The event was confirmed via provided photographs of the device and clinician review of provided medical records.Method & results: product evaluation and results: the reported device was not returned; however, photographs were provided for review.The photographs show a ceramic head that has fractured into many fragments.The fragments are covered in blood and tissue.What appears to be black staining is present on the device, consistent with contact against a metal implant.Clinician review: a review of the provided medical records by a clinical consultant indicated: "conclusion/assessment: a pi report and x-ray show a tha with what appears to be a fractured femoral head.Photographs also showed a fractured ceramic head.No clinical history or medical records were provided for review.The failure appears to have occurred at approximately 9 months.Event confirmation: a failure of the femoral head can be confirmed.Revision surgery cannot be confirmed without additional records.Root cause: the root cause of the unconfirmed revision would be fracture of the femoral head.The root cause of the head failure cannot be ascertained." 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 ceramic head fractured during surgery.The reported device was not returned; however, photographs were provided for review.The photographs show a ceramic head that has fractured into many fragments.The fragments are covered in blood and tissue.What appears to be black staining is present on the device, consistent with contact against a metal implant.A review of the provided x-rays by a consulting clinician indicated the following confirmed fracture of the ceramic head.Further information such as return of the device 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 devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: DELTA V-40 CERAMIC HEAD 36/+7,5
• Type of Device: 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: 18326364
• MDR Text Key: 330497133
• Report Number: 0002249697-2023-01562
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 04546540608581
• UDI-Public: 04546540608581
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6570-0-736
• Device Lot Number: 97264702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 108 KG
• Patient Race: White