MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 LONGEVITY 40MM I.D. SIZE F HIGH WALL LINER; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Difficult to Insert (1316); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the liner would not lock into the cup.The doctor said he saw irregularities on the liner like the plastic was not formed correctly.A second liner was able to be implanted.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).The product has been received by zimmer biomet and 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
Product was returned and evaluated.Visual examination of the returned product identified high wall, cutouts, and anti-rotation scallops that have indentations and gouges.The inner spherical surface exhibited damage consistent with possible tool marks.Device damage appeared to show attempted use.No other damage was noted.The device was measured and found to meet product specifications where it was measured.Review of the device history records identified no deviations or anomalies during manufacturing.Unable to perform a compatibility check as insufficient information was provided.Medical records were not provided.A definitive root cause cannot be determined for the liner not assembling to the cup.No problem was found with the device regarding the claim of irregularities and the plastic not being formed correctly.All the product identifiers were conforming to specification both visually and ones that were measured.The device was also visually inspected during manufacturing.The reported complaint cannot be confirmed.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 LONGEVITY 40MM I.D. SIZE F HIGH WALL LINER
• Common Device Name: PROSTHESIS, HIP
• 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: 20344448
• Report Number: 0001822565-2024-03114
• Device Sequence Number: 15467590
• Product Code: LPH
• UDI-Device Identifier: 00889024519381
• UDI-Public: (01)00889024519381(17)290422(10)66653552
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2025

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 Model Number: N/A
• Device Catalogue Number: 20124006
• Device Lot Number: 66653552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2024
• 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: 09/11/2024
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Female