MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DUAL MOBILITY VIVACIT E; PROSTHESIS, HIP

Catalog Number	110031012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat: 650-1055 lot: 3031481 cer bioloxd option hd 28mm.Cat: 650-1065 lot: 3048758 cer option type 1 tpr sleve -3.Cat: 010000664 lot: 7035252 g7 pps ltd acet shell 54f.Cat: 110024464 lot: 370560 g7 dual mobility liner 44mm f.Cat: 51-107110 lot: 6883354 tprlc 133 mp type1 pps ho 11.0.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that post-implantation, the patient is experiencing multiple issues: a metallic taste in the mouth and has corresponding nickel allergy; a rash on their leg; feelings of their femur shifting; two rounds of antibiotic treatment and iv antibiotics for infection; inability to walk much; toes go numb when laying on side; heart attack like symptoms; back pain; potassium and magnesium infusions for unknown reason making them feel worse; alleged metal in urine that surgeon thinks is a kidney stone; other green particles in urine suspected as suture pieces.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: g3; h2; h3; h6; h10.The following sections were corrected: b2; d4 udi.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.Complaint is not 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: DUAL MOBILITY VIVACIT E
• 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: 22809634
• Report Number: 0001822565-2025-02944
• Device Sequence Number: 18092423
• Product Code: LPH
• UDI-Device Identifier: 00889024572706
• UDI-Public: (01)00889024572706(17)260524(10)64934263
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K190656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/24/2026
• Device Catalogue Number: 110031012
• Device Lot Number: 64934263
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2021
• 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: Other; Required Intervention
• Patient Sex: Female