MAUDE Adverse Event Report: ZIMMER, INC.; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 6250-65-25

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/04/2020

Event Type  malfunction  

Event Description

The head of the acetabular bone screw broke off in patient.The remainder of the screw is left implanted.

• Brand Name: NA
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): ZIMMER, INC.; 1800 w. center street; warsaw IN 46580
• MDR Report Key: 9957095
• MDR Text Key: 187531992
• Report Number: 9957095
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6250-65-25
• Device Catalogue Number: 00-6250-065-25
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/14/2020
• Type of Device Usage: N
• Patient Sequence Number: 1