MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VIVACIT-E DM BEARING 28X54MM; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision procedure 9 days post implantation due to a fall from the toilet that resulted in a hip dislocation.On the post-dislocation x-rays, the polyethylene insert seems correctly fitted to the head.The post-reduction x-ray also shows that the insert is no longer coupled to the head, only the head is in the cup and the insert is in the soft tissues on the posterosuperior part of the hip which will be confirmed during the recovery.In addition, it appears that the head is not centered.There is a shape of a sphere that makes the surgeon think that it is disassociated from the cup but as the head and cup is in place.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).G2: foreign: switzerland.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 the patient underwent a revision procedure 8 days post implantation due to a fall that resulted in a hip dislocation.On the post-dislocation x-rays, the polyethylene insert seems correctly fitted to the head.The post-reduction x-ray also shows that the insert is no longer coupled to the head, only the head is in the cup and the insert is in the soft tissues on the posterosuperior part of the hip which will be confirmed during the recovery.In addition, it appears that the head is not centered.There is a shape of a sphere that makes the surgeon think that it is disassociated from the cup but as the head and cup is in place.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: d10 (b)(4) item name g7 osseoti 4 hole shell 66mm i lot # 6627167.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified the explanted bearing with some bio-debris on the outer spherical surface.No further evaluation can be made.Review of the device history records identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: images the right hip demonstrate a right total hip arthroplasty with dislocation and then normal position post reduction status post recent right hip surgery.It was identified that zimmer biomet devices were implanted with competitor devices.Zimmer biomet has not confirmed the compatibility for these combinations of devices.It is unknown if these off-label usages may have caused or contributed to the reported events.A definitive root cause cannot be identified.This complaint was confirmed based on the provided mmi review.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
There is no update to the prior event description provided.

• Brand Name: VIVACIT-E DM BEARING 28X54MM
• Common Device Name: PROSTHETIC, 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: 19907607
• Report Number: 0001822565-2024-02560
• Device Sequence Number: 8802790
• Product Code: LPH
• UDI-Device Identifier: 00889024572751
• UDI-Public: (01)00889024572751(17)270131(10)65343262
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 01/27/2025

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: 110031017
• Device Lot Number: 65343262
• 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: 07/26/2024
• Supplement Date Received by Manufacturer: 08/28/2024; 01/23/2025
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 09/10/2024; 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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: PLEASE SEE H11.; UNK HEAD AND UNKNOWN CUP.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Male