MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 FRDM CONST E1 10DEG LNR 36F; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 110010283-g7 frdm const e1 10deg lnr 36f-7012746.010000665- g7 pps ltd acet shell 56f-unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 03333.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the surgeon tried seating the g7 freedom size f liner into the cup without success.Surgeon opened another g7 freedom size f liner and tried seating the cup with the same results.After two wasted liners, a neutral freedom was opened and seated with first mallet blow.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Complaint sample was evaluated and the reported event was confirmed.Device history record (dhr) was reviewed and no discrepancies related to the event were found.Root cause was unable to be determined.Lot 7012750, visual inspection found the barb to be flattened and deformed in multiple locations.The barb is also scraped such that poly strands protrude from the liner.Deformation was also observed on the side wall of the liner.The outer radius of the liner is scratched and indented.Scratching was also observed on the rim.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: G7 FRDM CONST E1 10DEG LNR 36F
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13018390
• Report Number: 0001825034-2021-03334
• Device Sequence Number: 4872778
• Product Code: LPH
• UDI-Device Identifier: 00880304544581
• UDI-Public: (01)00880304544581(17)260427(10)7012750
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K142882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/27/2026
• Device Model Number: N/A
• Device Catalogue Number: 110010283
• Device Lot Number: 7012750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• 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: 11/22/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2021
• 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
• Patient Sex: Unknown