MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 DUAL MOBILITY LINER 44MM F; 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	01/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a revision surgery due to dual mobility dislocation and disassociation.The reason is unknown.The liner remains implanted.No additional information.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: cat# 00877502801 lot# 3127795 biolox⮠delta, ceramic femoral head, s, 㸠28/-3.5, taper 12/14, cat# 110010246 lot# 6336063 g7 osseoti 4 hole shell 56mm f, cat# 110031012 lot# 65207704 vivacit-e dm bearing 28x44mm, cat# 00-8114-000-10 lot# 64627384 cpt 12/14 size 0 cocr ext, cat# 010000998 lot# 6847823 g7 screw 6.5mm x 25mm, cat# 010000997 lot# 7074718 g7 screw 6.5x20, cat# 010000997 lot# 7202950 g7 screw 6.5x20.Foreign: country: japan.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4,d4,g3,h2,h3,h4,h6.No product was returned, or pictures provided; visual and dimensional evaluation could not be performed.Medical records were not provided.A review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.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 DUAL MOBILITY LINER 44MM F
• 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: 16283413
• Report Number: 0001825034-2023-00204
• Device Sequence Number: 17817825
• Product Code: LPH
• UDI-Device Identifier: 00880304703520
• UDI-Public: (01)00880304703520(17)320728(10)816310
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 03/23/2023

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 Model Number: N/A
• Device Catalogue Number: 110024464
• Device Lot Number: 816310
• 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: 01/23/2023
• Supplement Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2022
• 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: Unknown