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

Catalog Number UNK_JR

Device Problems Mechanical Problem (1384); Malposition of Device (2616); Positioning Problem (3009)

Patient Problem Injury (2348)

Event Date 10/15/2018

Event Type  Injury  

Manufacturer Narrative

An event regarding malposition rom issues (impingement) involving an unknown trident shell was reported.The event was confirmed through clinician review of the provided medical records.Method & results: device evaluation and results: not performed as the device remains implanted.Medical records received and evaluation: a review of the provided x-rays by a clinical consultant indicated: cup malposition has contributed to impingement between stem neck and cup rim causing stem neck damage with osteolysis around both stem and cup with periprosthetic fracture in the proximal femur requiring revision surgery with fracture stabilisation.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the investigation concluded that {.} cup malposition has contributed to impingement between stem neck and cup rim causing stem neck damage with osteolysis around both stem and cup with periprosthetic fracture in the proximal femur requiring revision surgery with fracture stabilization.{.} no further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Not returned to the manufacturer.

Event Description

The case was booked as a head and liner exchange.When the head was removed the surgeon decided the trunnion had damage and decided to remove the stem.On 12/12/2018: as per clinician review, cup malposition has contributed to impingement between stem neck and cup rim causing stem neck damage with osteolysis around both stem and cup with periprosthetic fracture in the proximal femur requiring revision surgery with fracture stabilization.

• Brand Name: UNKNOWN TRIDENT CUP
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8229117
• MDR Text Key: 132484260
• Report Number: 0002249697-2019-00106
• Device Sequence Number: 1
• Product Code: JDI
• 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: 01/08/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 01/08/2019
• 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