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

Model Number	6570-0-736
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a ceramic head was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: event description: as reported: "performed a left (mako) hip revision due to ceramic head fracture and gross trunnion failure.Original trident 2 cup stayed.No more information is available per doctor and implants will not be returned due to hospital policy." spoke to rep.The ceramic head cracked in half.Intraoperatively, wear and grooving of the trunnion of the stem was noted.It is not known if either device failure was the cause of the other.A stem, head and liner were revised.Rep confirmed there are no allegations against the revised liner.\ implant: delta v40 ceramic head 36mm +7.5mm, #6 accolade ii 1320 stem documents: 01/29/2021: stryker pi report.12/10/2019: op note, left primary daa mako hip, hand notes with gross trunnion failure, and head fx.Confirmation: the event cannot be confirmed.Root cause: the root cause cannot be ascertained without additional medical records and perhaps the retrieved implants.Product history review: review of the device history records indicates 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 lot referenced.Conclusions: a review of the provided medical records by a clinical consultant stated the following comment: the event cannot be confirmed [.] the root cause cannot be ascertained without additional medical records and perhaps the retrieved implants.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report 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.
Event or Problem Description
As reported: "performed a left (mako) hip revision due to ceramic head fracture and gross trunnion failure.Original trident 2 cup stayed.No more information is available per doctor and implants will not be returned due to hospital policy." spoke to rep.The ceramic head cracked in half.Intraoperatively, wear and grooving of the trunnion of the stem was noted.It is not known if either device failure was the cause of the other.A stem, head and liner were revised.Rep confirmed there are no allegations against the revised liner.

• Brand Name: DELTA V-40 CERAMIC HEAD 36/+7,5
• 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
• MDR Report Key: 11371835
• Report Number: 0002249697-2021-00327
• Device Sequence Number: 3773734
• Product Code: LZO
• UDI-Device Identifier: 04546540608581
• UDI-Public: 04546540608581
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2021

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: 10/31/2024
• Device Model Number: 6570-0-736
• Device Catalogue Number: 6570-0-736
• Device Lot Number: 75358301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 02/24/2021
• 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: 48 YR
• Patient Weight: 99