MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 36/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	6570-0-136
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Fall (1848)
Date of Event	08/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's right hip was revised due to a fractured femoral head.Intra-operatively, the head was observed to be broken into several pieces and the liner was damaged.Surgeon reported the patient had a fall one month prior.The head and liner were revised.Rep reported that pictures can be provided, and confirmed that no further information will be released by the hospital or surgeon.
Additional 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.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a ceramic head was reported.The event was confirmed through clinician review of the provided medical records.Method & results: product evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review documentation related to pi including the product inquiry summary and an ap x-ray of a right total hip.The event description from the product inquiries summary states: it was reported that the patient's right hip was revised due to a fractured femoral head.Intra-operatively, the head was observed to be broken into several pieces and the liner was damaged.Surgeon reported the patient had had a fall one month prior.The head and liner were revised.Rep reported that pictures can be provided, and confirmed that no further information will be released by the hospital or surgeon.The ap x-ray demonstrates a pressfit tha.The femoral head has fractured in to multiple pieces.There is no evidence of component loosening or other mechanical complication.Fracture of the orosthetic femoral head is confirmed.The root cause for this complication cannot be determined from this limited documentation.Should additional information become available i would be happy to further this assessment.-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.Conclusion: a review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review documentation related to pi including the product inquiry summary and an ap x-ray of a right total hip.The event description from the product inquiries summary states: it was reported that the patient's right hip was revised due to a fractured femoral head.Intra-operatively, the head was observed to be broken into several pieces and the liner was damaged.Surgeon reported the patient had had a fall one month prior.The head and liner were revised.Rep reported that pictures can be provided, and confirmed that no further information will be released by the hospital or surgeon.The ap x-ray demonstrates a pressfit tha.The femoral head has fractured in to multiple pieces.There is no evidence of component loosening or other mechanical complication.Fracture of the orosthetic femoral head is confirmed.The root cause for this complication cannot be determined from this limited documentation.Should additional information become available i would be happy to further this assessment.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's right hip was revised due to a fractured femoral head.Intra-operatively, the head was observed to be broken into several pieces and the liner was damaged.Surgeon reported the patient had had a fall one month prior.The head and liner were revised.Rep reported that pictures can be provided, and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: DELTA V-40 CERAMIC HEAD 36/0
• 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: 15406490
• Report Number: 0002249697-2022-01325
• Device Sequence Number: 5653370
• Product Code: LZO
• UDI-Device Identifier: 04546540608512
• UDI-Public: 04546540608512
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K052718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2022

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: 03/31/2024
• Device Model Number: 6570-0-136
• Device Catalogue Number: 6570-0-136
• Device Lot Number: 71214202
• 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: 08/17/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2019
• 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 Sex: Male