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

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Dislocation (2374)
Date of Event	06/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat#00877502802; lot#3201984; bioloxâ® delta, ceramic femoral head, m, 㸠28/0, taper 12/14.G2: foreign ¿ belgium.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 approximately one day post-implantation, the patient underwent a hip revision due to a fall and hip dislocation.During surgery, the surgeon found an intra-prosthetic dislocation of the head out of the bearing.The head and bearing were revised.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).The product has been received by zimmer biomet and 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 approximately one day post-implantation, the patient underwent a hip revision due to a fall and hip dislocation.During surgery, the surgeon found an intra-prosthetic dislocation of the head out of the bearing.The stem, head, and bearing were revised.Attempts have been made and no further information has been provided.
Event or Problem Description
It was reported that approximately one day post-implantation, the patient underwent a hip revision due to a fall that was caused by pain and then the hip dislocated.During surgery, the surgeon found an intra-prosthetic dislocation of the head out of the bearing.The head and bearing were revised.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4; b5; g3; h2; h3; h4; h6.Visual review of the returned liner is unable to confirm item or lot as there is no etch on size 40mm per delta note 1 on the print.Liner shows indentations to the other spherical surface.Nicks in the inner spherical surface and on the rim.No other damage was noted.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues.Impressions: recent postsurgical changes from left total hip arthroplasty with evidence of superior and likely posterior dislocation of the femoral component.The event of disassociation between the head/bearing is confirmed via medical records.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive root cause cannot be determined.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.

• Brand Name: DUAL MOBILITY VIVACIT-E BEARING SIZE D
• 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: 19615466
• Report Number: 0001822565-2024-02146
• Device Sequence Number: 20368592
• Product Code: LPH
• UDI-Device Identifier: 00889024572683
• UDI-Public: (01)00889024572683(17)270809(10)65560546
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K190656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 12/10/2024

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110031010
• Device Lot Number: 65560546
• 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: 06/14/2024
• Supplement Date Received by Manufacturer: 07/04/2024; 11/21/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 07/29/2024; 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2022
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown