MAUDE Adverse Event Report: HOWMEDICA OSTEONICS CORP., AKA STRYKER ORTHOPAEDICS TRIDENT ACETABULAR SYSTEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 623-10-36E

Device Problems Metal Shedding Debris (1804); Device Operates Differently Than Expected (2913)

Patient Problems Complaint, Ill-Defined (2331); Reaction (2414)

Event Date 09/15/2014

Event Type  malfunction  

Event Description

Received a letter from patient's attorney on sequestering an explant for patient's upcoming hip surgery.Pre-procedure diagnosis: failed right total hip arthroplasty with metallosis and metal reaction.Post-procedural diagnosis: same.Procedure: revision, right total hip arthroplasty, femoral component and acetabular liner.

• Brand Name: TRIDENT ACETABULAR SYSTEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): HOWMEDICA OSTEONICS CORP., AKA STRYKER ORTHOPAEDICS; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 5297674
• MDR Text Key: 33516687
• Report Number: 5297674
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2015,11/12/2015

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: No Information
• Device Model Number: 623-10-36E
• Device Catalogue Number: 623-10-36E
• Device Lot Number: UNKNOWN
• Other Device ID Number: LNR 10 DEG OD50-52MM ID 36MM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other