MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 VIT E HIGH WALL LNR 40MM F; PROTHESIS, HIP

Catalog Number	30124006
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during hip surgery, the liner would not seat into the cup.During impaction of the final liner, the surgeon always checks to see that it is well seated, and it wasn¿t.The surgeon re-impacted the liner: however, it still didn¿t seat right in the cup.Another liner was used, and it impacted in the first try.The liner was visually inspected, and it did not appear broken.No screws in the cup were used.It was reported that the surgeon used the same technique as usual.There was a one-minute delay for getting the other liner and opening it.There was no patient impact and no surgical complications.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).D10: cat# 010000664 lot# j7913001 g7 pps ltd acet shell 54f.G2: foreign country: canada.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information and corrected information.The following section was corrected: h4 the following sections were updated: b4;d9;g3;h2;h3;h6 product was returned and evaluated.Visual examination of the returned product identified major scratches and nicks within the inner diameter.There were also scratches on the outside tapered surface near the anti-rotation scallops; and the outside rim lock feature visually appeared to have a rolled edge; no other damage was noted.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.A definitive root cause cannot be determined.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 is available at the time of this report.

• Brand Name: G7 VIT E HIGH WALL LNR 40MM F
• Common Device Name: PROTHESIS, 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: 22736961
• Report Number: 0001822565-2025-02833
• Device Sequence Number: 21142225
• Product Code: LPH
• UDI-Device Identifier: 00889024520547
• UDI-Public: (01)00889024520547(17)300222(10)67145547
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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 Catalogue Number: 30124006
• Device Lot Number: 67145547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/30/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2025
• 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: Unknown