MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 36/+2,5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6570-0-536
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	02/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 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.
Event or Problem Description
As reported: "dr.Performed a left hip revision due to gross trunnion failure and fractured biolox head.No more information is available per doctor.Implant is not available per hospital policy" a 36 + 2.5 mm biolox ceramic v40 head, size 5 132° accolade ii hip stem, and 36f liner were revised.Spoke to rep: there are no allegations against the revised liner.Confirmed that other than attached explant pictures and usage sheet, no further information would be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a ceramic head was reported.The event was confirmed based on the provided picture.Method & results: product evaluation and results: material analysis, functional and dimensional inspections could not be performed as the device was not returned.Visual inspection - the reported device was not returned however photographs were provided for review.The photographs shows an explanted and broken ceramic head in a plastic container.From the photographs provided there is evidence of crack/fracture of the device.Clinician review: no medical records were received for review with a clinical consultant   device history review: all 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 reported lot.  conclusions: the event reported crack/fracture involving a ceramic head was reported.The event was confirmed based on provided picture.The exact cause of the event could not be determined because insufficient information was provided.Further information 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.
Event or Problem Description
As reported: "dr.Performed a left hip revision due to gross trunnion failure and fractured biolox head.No more information is available per doctor.Implant is not available per hospital policy" a 36 + 2.5 mm biolox ceramic v40 head, size 5 132° accolade ii hip stem, and 36f liner were revised.Spoke to rep: there are no allegations against the revised liner.Confirmed that other than attached explant pictures and usage sheet, no further information would be released by the hospital or surgeon.

• Brand Name: DELTA V-40 CERAMIC HEAD 36/+2,5
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11507494
• Report Number: 0002249697-2021-00477
• Device Sequence Number: 2776379
• Product Code: JDI
• UDI-Device Identifier: 04546540608574
• UDI-Public: 04546540608574
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2021

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: 09/30/2017
• Device Model Number: 6570-0-536
• Device Catalogue Number: 6570-0-536
• Device Lot Number: 41444001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 84