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

Catalog Number UNK_JR

Device Problems Malposition of Device (2616); Material Deformation (2976)

Patient Problems Inflammation (1932); Injury (2348); Reaction (2414)

Event Date 01/22/2018

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported that patient's right hip was revised due to high cobalt levels and neck fracture of stem.Update 29 jan 2018: a review by a clinical consultant has confirmed a trident shell malposition and impingement.

Manufacturer Narrative

An event regarding malposition involving a trident shell was reported.The event was confirmed through review of the provided medical records and x-rays by a clinical consultant.Conclusions: the investigation concluded that {.} cup malposition in absent anteversion has contributed to impingement with overload in the bearing section of the arthroplasty causing excessive micro motion between stem taper and femoral head leading to catastrophic taper damage as final effect with dissociation of the femoral head from the taper.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that patient's right hip was revised due to high cobalt levels and neck fracture of stem.Update 29 jan 2018: a review by a clinical consultant has confirmed a trident shell malposition and impingement.

• Brand Name: UNKNOWN TRIDENT SHELL
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7277222
• MDR Text Key: 100284179
• Report Number: 0002249697-2018-00453
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 100 YR
• Patient Weight: 61