MAUDE Adverse Event Report: ZIMMER INC. G7 SHELL ACETAB 3HX54MMF; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 10000664

Device Problem Nonstandard Device (1420)

Patient Problem Post Operative Wound Infection (2446)

Event Date 08/22/2022

Event Type  Injury  

Event Description

Pt underwent a total left hip on (b)(6) 2022; a zimmer g7 shell acetabulum 3hx554mmf was used; zimmer had a recent recall on g7 shell implants; patient developed a surgical site infection.Fda safety report id # (b)(4).

• Brand Name: G7 SHELL ACETAB 3HX54MMF
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): ZIMMER INC.; warsaw IN 46580
• MDR Report Key: 15680442
• MDR Text Key: 302604629
• Report Number: MW5112898
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00880304524231
• UDI-Public: 0100880304524231
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/25/2022

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: Health Professional
• Device Catalogue Number: 10000664
• Device Lot Number: 7216584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 131 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White