MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VIVACIT-E DM BEARING 28X50MM; PROSTHESIS, HIP

Catalog Number	110031015
Medical Device Problem Codes	Positioning Failure (1158); Unclear Information (4052)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: medical product: unknown avantage shell: catalog#ni, lot#ni.G2: foreign, (b)(6).The 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 that during an initial total hip arthroplasty, the correct inlay was opened for the shell however the inlay would not fit and was unable to be properly positioned.A backup device was used to the complete the procedure without further complication.There was no patient impact and no adverse events have been reported as a result of the malfunction.

• Brand Name: VIVACIT-E DM BEARING 28X50MM
• 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: 24380550
• Report Number: 0001822565-2026-00544
• Device Sequence Number: 13391484
• Product Code: LPH
• UDI-Device Identifier: 00889024572737
• UDI-Public: (01)00889024572737(17)300320(10)67151495
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 05/07/2026

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: 110031015
• Device Lot Number: 67151495
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Patient Sex: Unknown