MAUDE Adverse Event Report: ZIMMER BIOMET INC. G7 ACETABULAR SYSTEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/06/2023

Event Type  Injury  

Event Description

It was reported that the patient was revised due to loosening of zimmer cup.Previous duel mobility with a summit stem.Surgeon removed cup, surgeon, implanted g7 multi hole with zimmer dual mobility and implanted the same ts ceramic 28+5 head.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: G7 ACETABULAR SYSTEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): ZIMMER BIOMET INC.
• MDR Report Key: 17967739
• MDR Text Key: 326233947
• Report Number: MW5147122
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 10/17/2023

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/18/2023
• Patient Sequence Number: 1