MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 28MM A; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Osteopenia/ Osteoporosis (2651)
Date of Event	12/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was revised approximately three weeks post implantation due to dislocation.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).D10: cat# 802202802 lot# 3155947 femoral head 12/14 taper 28 mm diameter +0 mm neck length g2: foreign ¿ australia the customer has indicated that the product will not be returned to zimmer biomet for investigation as it was not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Complaint confirmed based on the evaluation of the provided x-rays.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Radiographs and reviewed by a health care professional and identified the following: implant fit is maintained.Regarding alignment, there is a left hip dislocation.There is malalignment secondary to dislocation.No loosening or abnormal radiolucency.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 HI-WALL E1 LINER 28MM A
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18418138
• Report Number: 0001825034-2023-03090
• Device Sequence Number: 20824443
• Product Code: PBI
• UDI-Device Identifier: 00880304526907
• UDI-Public: (01)00880304526907(17)241003(10)6642575
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2024

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: Lay User/Patient
• Device Expiration Date: 10/03/2024
• Device Model Number: N/A
• Device Catalogue Number: 010000913
• Device Lot Number: 6642575
• 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: 12/07/2023
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2019
• 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: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 55 KG