MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM CLUSTER54E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	702-04-54E
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	03/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: delta v-40 ceramic head 36/+7,5;6570-0-736; 68112802.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding dislocation involving a trident shell was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection of the returned device noted the following: examination of the device returned indicated nothing remarkable to report.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as 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 additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Dr.Brought the patient back for dislocation.Removed head and liner.Went to a larger head with longer neck length.

• Brand Name: TRIDENTII TRITANIUM CLUSTER54E
• 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: 10128036
• Report Number: 0002249697-2020-01085
• Device Sequence Number: 16984429
• Product Code: JDI
• UDI-Device Identifier: 07613327344073
• UDI-Public: 07613327344073
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K171768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/08/2020

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: 10/31/2023
• Device Model Number: 702-04-54E
• Device Catalogue Number: 702-04-54E
• Device Lot Number: 68454601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 06/08/2020
• 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