MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 ACETABULAR SYSTEM VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER

Catalog Number 30103607

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Bone Fracture(s) (1870); Joint Dislocation (2374)

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: item# 110010247; lot# 6630992.Item# 650-1057; lot# 2958797.Item# 650-1068; lot# 2965056.Item# 51-103140; lot# 6626648.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Dhr was reviewed and no discrepancies relevant to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: acetabuli protrusio of the acetabular component with subsidence of the femoral component and dislocation of the femoral head.Fracture superomedial and anterior acetabulum.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported by the pmi group that a patient underwent a right hip arthroplasty on an unknown date.Subsequently, the patient is being considered for a pmi product on an unknown day for an unknown reason.X-rays received and reviewed, noting loosening of the acetabular component, subsidence of the femoral component, dislocation of the femoral head, and bone fracture of the acetabulum.Attempts have been made and no further information has been provided.

• Brand Name: G7 ACETABULAR SYSTEM VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19116668
• MDR Text Key: 340284980
• Report Number: 0001822565-2024-00453
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024519923
• UDI-Public: (01)00889024519923(17)240630(10)64358597
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 30103607
• Device Lot Number: 64358597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male