MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIDENT SHELL; HIP IMPLANT

Catalog Number UNK_SHC

Device Problem Malposition of Device (2616)

Patient Problem Injury (2348)

Event Date 03/09/2017

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving an unknown trident shell was reported.Shell malposition was confirmed following a review by a clinical consultant.Method & results: -device evaluation and results: was not performed as the device remains implanted.-medical records received and evaluation: a review of the provided x-rays and photos by a clinical consultant indicated; [.]procedure-related factors: - cup malposition in excessive anteversion.Patient-related factors - none evident.Device-related factors: - none.Diagnosis: - cup malposition in excessive anteversion has caused impingement with overload on the ceramic bearing and ultimately a ceramic rim fracture consistent with x-ray and explant findings.[.] -device history review: not performed as the device lot number is unknown.-complaint history review: not performed as the device lot number is unknown.Conclusions: a review of the provided x-ray and medical notes by a clinical consultant concluded: [.] cup malposition in excessive anteversion has caused impingement with overload on the ceramic bearing and ultimately a ceramic rim fracture consistent with x-ray and explant findings.[.] no further investigation for this event is possible at this time.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Sales rep reported a left hip revision due to fractured ceramic liner.

• Brand Name: UNKNOWN TRIDENT SHELL
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: sarah smelko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6607940
• MDR Text Key: 76523386
• Report Number: 0002249697-2017-01761
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 78