MAUDE Adverse Event Report: ZIMMER, INC. TRILOGY ACETABULAR SYSTEM, BONE SCREW; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNC

Catalog Number 6250-65-35

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/20/2014

Event Type  malfunction  

Event Description

During total hip arthroplasty, self-tapping bone screw broke at the head, retained in bone.

• Brand Name: TRILOGY ACETABULAR SYSTEM, BONE SCREW
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNC
• Manufacturer (Section D): ZIMMER, INC.; 345 e main street; warsaw IN 46580
• MDR Report Key: 4293215
• MDR Text Key: 5271139
• Report Number: 4293215
• Device Sequence Number: 1
• Product Code: LPH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 6250-65-35
• Device Lot Number: 62793503
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/20/2014
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/20/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NOT KNOWN.
• Patient Age: 49 YR
• Patient Weight: 100