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
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Joint Dislocation (2374)
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.

• Brand Name: G7 ACETABULAR SYSTEM VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINER
• Common Device Name: 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
• Report Number: 0001822565-2024-00453
• Device Sequence Number: 12687488
• Product Code: LPH
• UDI-Device Identifier: 00889024519923
• UDI-Public: (01)00889024519923(17)240630(10)64358597
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male