MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM CLUSTER52E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	702-04-52E
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	05/26/2019
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.
Event or Problem Description
It was reported that the patient's hip was revised.A pre-revision x-ray showed the cup spun with it rim facing vertically upwards.Intra-operatively, the poly insert was found to have dislocated from the metal mdm liner.A stage 1 revision was performed due to suspected infection (it is unknown if infection was clinically confirmed or identified).An antibiotic spacer was placed.Rep provided a picture of the explants, an implant report, and a pre-revision x-ray and reported that no further information is available.
Additional Manufacturer Narrative
An event regarding loosening and infection involving a trident shell was reported.The event of loosening was confirmed by medical review.The event of infection was not confirmed.Method & results: -device evaluation and results: visual inspection of the received image of the device noted the explanted device was packaged in a poly bag.Dimensional, functional and material analysis not performed as the device was not returned for evaluation.-clinician review: the available medical records were provided to the consulting clinician for a review which was rejected stating - "provided x-ray confirms loose acetabular and dislocation but the reported event for infection cannot be confirmed.Need operative reports, office/clinical reports, serial x-rays, and examination of the explanted components." -device history review: not performed as the device was not identified properly.-complaint history review: not performed as the device was not identified properly.Conclusions: it was reported that the patient's hip was revised.A pre-revision x-ray showed the cup spun with it rim facing vertically upwards.Intra-operatively, the poly insert was found to have dislocated from the metal mdm liner.A stage 1 revision was performed due to suspected infection.Visual inspection of the received image of the device noted the explanted device was packaged in a poly bag.The available medical records were provided to the consulting clinician for a review which was rejected stating that the provided x-ray confirms loose acetabular and dislocation but the reported event for infection cannot be confirmed.Need operative reports, office/clinical reports, serial x-rays, and examination of the explanted components.The event of loosening was confirmed and the root cause could not be identified as insufficient information was available.The event of infection could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient information was provided.Further information such as return of device, pre- and post-op x- rays, patient history, pathology report & follow-up notes are needed to investigate this event further.Although the device information is not provided, all stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10-6 in accordance to applicable iso standards.If additional information and/or device becomes available, this investigation will be reopened.
Event or Problem Description
It was reported that the patient's hip was revised.A pre-revision x-ray showed the cup spun with it rim facing vertically upwards.Intra-operatively, the poly insert was found to have dislocated from the metal mdm liner.A stage 1 revision was performed due to suspected infection (it is unknown if infection was clinically confirmed or identified).An antibiotic spacer was placed.Rep provided a picture of the explants, an implant report, and a pre-revision x-ray and reported that no further information is available.

• Brand Name: TRIDENTII TRITANIUM CLUSTER52E
• 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: 8721886
• Report Number: 0002249697-2019-02330
• Device Sequence Number: 2472303
• Product Code: LPH
• UDI-Device Identifier: 07613327343915
• UDI-Public: 07613327343915
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K171768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/07/2019

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 Catalogue Number: 702-04-52E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/26/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 08/07/2019
• 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; Disability
• Patient Age: 87 YR
• Patient Weight: 88