MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 32MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 623-10-32D

Device Problems Device Dislodged or Dislocated (2923); No Apparent Adverse Event (3189)

Patient Problem Joint Dislocation (2374)

Event Date 12/22/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revision of a primary right hip due to dislocation.Surgeon revised the head and liner for a more stable construct.

Manufacturer Narrative

An event regarding an alleged dislocation involving a trident 10° x3 insert (liner) 32mm id was reported.Conclusions: review of the provided medical records and x-rays was performed by a clinical consultant concluded that the shell was placed in a horizontal position during primary surgery and that surgical technique contributed to dislocations and the need for a revision surgery in 2015.Additionally, the photos reveal impingement deformities, as seen on the inner lip of the liner.There was no indication that the trident 10° x3 insert contributed to this event.Based on the provided information, the product reported in this investigation did not contribute to the event.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

Revision of a primary right hip due to dislocation.Surgeon revised the head and liner for a more stable construct.

• Brand Name: TRIDENT 10° X3 INSERT 32MM ID
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 5378355
• MDR Text Key: 36343816
• Report Number: 0002249697-2016-00137
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033716
• 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: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2011
• Device Catalogue Number: 623-10-32D
• Device Lot Number: EVKMEA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/24/2006
• 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): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 90