MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Catalog Number 625-0T-32E

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2016

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

Ceramic insert breakage after 6 years of being implanted.

Manufacturer Narrative

An event regarding a crack/fracture involving a trident liner was reported.A visual inspection of an image of the liner confirmed crack/fracture.Method & results: -device evaluation and results: visual inspection was performed as part of the material analysis report.The report noted: the parts were examined with the aid of a stereo microscope at magnifications up to 50x.The approximately 20% of the insert was returned.Secondary chipping was observed on the fracture surfaces on the alumina insert as.Secondary chipping obscured the location of fracture origin and fracture propagation, making it impossible to identify the root cause of the fracture.The damage observed on the alumina head is consistent with contact with the alumina insert remains and the underlying titanium sleeve.-medical records received and evaluation: a review of the provided information by a clinical consultant noted: cup inclination was only 29° where the target value for optimal inclination ranges between 40° - 45°.Anteversion appears to be within the normal range with 16° although there is no lateral x-ray available for cross-check.Cup malposition is thus proven.Such cup malposition may contribute to overload in the bearing section of the arthroplasty due to edge loading, impingement, subluxation or otherwise adverse biomechanical effects.[.] with ceramic-on-ceramic bearings such subluxation causes extremely high point contact loads between the opposing ceramic surfaces, easily surpassing the mechanical strength of the ceramic material.Fracture through overload then becomes a real risk.-device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusions: a report by a clinical consultant concluded: cup malposition in very low inclination has contributed to an overload condition in the ceramic bearing due to edge loading and/or impingement.Rim loading and even a single subluxation are known to possibly cause a ceramic liner fracture.Further information such as operative reports, additional x-rays, patient history & follow-up notes are needed to investigate this event further.If additional information becomes available, this investigation will be reopened.

Event Description

Ceramic insert breakage after 6 years of being implanted.

• Brand Name: TRIDENT ALUMINA INSERT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5697960
• MDR Text Key: 46513329
• Report Number: 0002249697-2016-01790
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P000013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/06/2016

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 Expiration Date: 07/31/2014
• Device Catalogue Number: 625-0T-32E
• Device Lot Number: 30756003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/06/2016
• Initial Date FDA Received: 06/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2009
• 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