MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 VIT E NEUTRAL LNR 36MM D; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Subluxation (4525)
Date of Event	02/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent am initial left total hip arthroplasty.Subsequently, the patient was revised two (2) months post implantation due to polyethylene wear.During the revision subluxation of the insert was noted, the shell, liner, and head were revised without complications.
Additional Manufacturer Narrative
(b)(4).D10: 010000702 g7 bonemaster ltd acet shl 50d 7817865.650-0660 delta ceramic fem hd 36/-3mm 3217040.G2: foreign: belgium.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
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: d4, d9, g3, g6, h2.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; h2; h3; h4; h6.Visual examination of the returned product identified the inner diameter of the liner has scratches and gouges in multiple areas.The top flat surface has gouges and indentations.2/12 anti-rotation scallops are damaged/deformed and partially removed from device but still attached.5/12 anti-rotation scallops are completely damaged/missing from device.The outside tapered surface and rimlock surface have deformations, gouges, and scratches.Review of the device history record identified no deviations or anomalies during manufacturing.Radiographs were provided.Review identified the following: single ap view of the left hip demonstrates intraoperative fluoroscopic image with femoral reamer in place as well as acetabular cup from left total hip arthroplasty placement.Single ap view of the pelvis demonstrates a left total hip arthroplasty with asymmetric position of the femoral head with the acetabular cup which could indicate underlying polyethylene wear.Single ap view of the left hip demonstrates a left total hip arthroplasty with persistent asymmetric position of the femoral head within the acetabular cup suggesting polyethylene wear.Surrounding subcutaneous emphysema now seen.Medical records identified the following: patient had a initial tha, subsequently was revised due to early wear of polyethylene insert.Subluxation was noted of the insert.The head, shell and liner were revised without complications.A definitive root cause cannot be determined.Based on the returned product review, the complaint is 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.
Event or Problem Description
No further information is available at the time of this report.

• Brand Name: G7 VIT E NEUTRAL LNR 36MM D
• Common Device Name: PROSTHESIS, HIPS
• 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: 21425362
• Report Number: 0001822565-2025-00433
• Device Sequence Number: 15450330
• Product Code: LPH
• UDI-Device Identifier: 00889024519893
• UDI-Public: (01)00889024519893(17)290529(10)66747524
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 06/20/2025

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 30103604
• Device Lot Number: 66747524
• 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: 02/10/2025
• Supplement Date Received by Manufacturer: 03/19/2025; 05/30/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 04/11/2025; 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown