MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM CLUSTER48D; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	702-04-48D
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/02/2019
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.Device not returned.
Event or Problem Description
It was reported that the patient's left hip was revised 19 days after implantation due to the acetabular shell becoming dislocated from the patient's acetabulum.Possible cause or contributor for dislocation was not reported to the rep.A shell, liner and femoral head were revised to a shell with screws, liner, and femoral head.
Additional Manufacturer Narrative
An event regarding loosening involving a trident shell was reported.A medical review confirm loosening of the shell.Method & results: -product evaluation and results: not performed as the device was not returned.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: "deemed insufficient for medical review : provided x-rays confirm event.Need operative reports, office/clinical reports, serial x-rays, and examination of the explanted components." -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 were no other events for the lot provided.Conclusions: a review of the provided medical records by a clinical consultant stated the following comment: "deemed insufficient for medical review : provided x-rays confirm event.Need operative reports, office/clinical reports, serial x-rays, and examination of the explanted components." no further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's left hip was revised 19 days after implantation due to the acetabular shell becoming dislocated from the patient's acetabulum.Possible cause or contributor for dislocation was not reported to the rep.A shell, liner and femoral head were revised to a shell with screws, liner, and femoral head.Rep provided pre-revision x-rays, primary and revision implant sheets and reported that no further information will be available.

• Brand Name: TRIDENTII TRITANIUM CLUSTER48D
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8527937
• Report Number: 0002249697-2019-01664
• Device Sequence Number: 1871240
• Product Code: LPH
• UDI-Device Identifier: 07613327343861
• UDI-Public: 07613327343861
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2019

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: 09/30/2023
• Device Catalogue Number: 702-04-48D
• Device Lot Number: 67643701A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/23/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 06/12/2019
• 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: 63 YR