MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 32/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	6570-0-132
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/05/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Patients sister left voicemail on patient hotline reporting three right hip dislocations of trident components over a two month period.Patients sister is also inquiring about a product recall.Femoral head was the only component provided.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation involving a ceramic head was reported.The event was not confirmed.Method & results: device evaluation and results: material analysis, visual, functional, and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were provided for review with clinical consultant.Device 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 has been no other similar events for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device return, 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.It is noted that the customer inquired if the device is part of a product recall.Based on the catalog and lot codes provided the reported device is not subject to a recall.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
Patients sister left voicemail on patient hotline reporting three right hip dislocations of trident components over a two month period.Patients sister is also inquiring about a product recall.Femoral head was the only component provided.Update: patients sister left voicemail on patient hotline reporting two right hip dislocations of trident components; february 13th and 18th.Patient required a "closed reduction and a brace to keep hip and thigh in place".

• Brand Name: DELTA V-40 CERAMIC HEAD 32/0
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16021886
• Report Number: 0002249697-2022-01866
• Device Sequence Number: 5859213
• Product Code: LZO
• UDI-Device Identifier: 04546540608505
• UDI-Public: 04546540608505
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K052718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2023

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: 09/30/2024
• Device Model Number: 6570-0-132
• Device Catalogue Number: 6570-0-132
• Device Lot Number: 74972102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2022
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2019
• 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: Required Intervention; Other; Hospitalization
• Patient Sex: Female