MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 36MM G; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately one year post-implantation, the patient was revised due to a dislocation.The head was exchanged and the liner remained implanted.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: cat# 00877503602 lot# 3032400 bioloxâ® delta, ceramic femoral head, m, 㸠36/0, taper 12/14.G2: foreign ¿ new zealand.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no related deviations or anomalies during manufacturing.Medical records/radiographs were provided.Review of the available records identified findings of the reported issues.Findings: ¿ posterior approach, asa ii ¿ dislocation ¿ change head.A definitive root cause cannot be determined.The event is confirmed via medical records.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 or Problem Description
No further information is available at the time of this report.

• Brand Name: G7 HI-WALL E1 LINER 36MM G
• 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: 18790687
• Report Number: 0001825034-2024-00539
• Device Sequence Number: 18067934
• Product Code: PBI
• UDI-Device Identifier: 00880304527126
• UDI-Public: (01)00880304527126(17)250827(10)6854147
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 07/02/2024

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: 08/27/2025
• Device Model Number: N/A
• Device Catalogue Number: 010000937
• Device Lot Number: 6854147
• 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: 02/06/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male