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-32F

Device Problems Fracture (1260); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 03/09/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.

Event Description

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

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving trident liner was reported.The event was confirmed.Method & results: -device evaluation and results: the device was not returned however a photo was provided.An inspection of this photo showed an impingement dent on the metal rim of the sleeve.There was also a fracture on the ceramic rim of this liner.Otherwise the device was unremarkable.-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: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: review indicated there have been no other similar events for the reported lot.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: 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: jadwiga degrado ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6460269
• MDR Text Key: 71717971
• Report Number: 0002249697-2017-01135
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000013
• 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,Followup
• Report Date: 06/09/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2011
• Device Catalogue Number: 625-0T-32F
• Device Lot Number: 19449303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2017
• Initial Date FDA Received: 04/05/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2006
• 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