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

Catalog Number UNK_SHC

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

Patient Problem Injury (2348)

Event Date 05/09/2017

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving an unknown ceramic head was reported.Malposition of the unknown trident shell was confirmed through a medical review.Method & results: - device evaluation and results: not performed as device was not returned.- medical records received and evaluation: a review of the provided mar and x-rays by a clinical consultant noted the following; procedure-related factors: - cup malposition in low inclination (30°) with probably a further low anteversion factor.Patient-related factors - none device-related factors: - none as also supported by mar findings.Diagnosis: - cup malposition in low inclination (30°) with probably a further low anteversion factor has contributed to abnormal biomechanics with overload in the arthroplasty with edge loading, wear scar formation and finally a fatigue type of fracture in the ceramic head.-device history review could not be performed as the device lot is unknown.-complaint history review could not be performed as the device lot is unknown.Conclusion: a clinical consultant concluded the following: cup malposition in low inclination (30°) with probably a further low anteversion factor has contributed to abnormal biomechanics with overload in the arthroplasty with edge loading, wear scar formation and finally a fatigue type of fracture in the ceramic head.No further investigation for this event is possible at this time.If additional information become available, this investigation will be reopened.

Event Description

The customer reported that a ceramic head, implanted in 2003, broke.A revision operation is planned for (b)(6) 2017.The ceramic head was placed on an abg stem.

• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6765201
• MDR Text Key: 81757101
• Report Number: 0002249697-2017-02370
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2017
• 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: 07/07/2017
• 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: 80 YR
• Patient Weight: 75