MAUDE Adverse Event Report: Zimmer Biomet, Inc. G7 VIT E NEUTRAL LNR 32MM C; Prosthesis, Hip

Catalog Number	30103203
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Bursitis (4832); Tendinopathy (4887)
Date of Event	05/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported in a clinical study that the patient received a cortisone injection approximately one-year post-implantation due to iliopsoas tendinitis, bursitis, and pain.The event was marked as ongoing but improving with no further complications reported at this time.No additional information available for the reported event.
Additional Manufacturer Narrative
(b)(4).D10: biolox⮠delta, ceramic femoral head, l, 㸠32/+3.5, taper 12/14, item: 00877503203, lot: 3236486, z1 std col cmtless sz 0, item: 611201000, lot: zb2400296, g7 pps ltd acet shell 48c, item: 010000661, lot: j8011790.The customer indicated that the product remains implanted; therefore, it will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.

• Brand Name: G7 VIT E NEUTRAL LNR 32MM C
• 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 ; +1(574)526-0384
• MDR Report Key: 50914783
• Report Number: 0001822565-2026-03252
• Device Sequence Number: 5393539
• Product Code: LPH
• UDI-Device Identifier: 00889024519831
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 30103203
• Device Lot Number: 67456986
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: See H11.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 115 LB
• Patient Race: White