MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ACT ARTIC E1 HIP BRG 28X40MM; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Joint Dislocation (2374)
Date of Event	10/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision procedure two years post implantation due to dislocation.Patient had a fall at some point and then had an episode of dislocation.The hip was attempted to be relocated in the emergency department - surgeon feels at this point the poly 40mm head was pulled off the 28mm bearing and then was sitting loose in the joint space.The hip was revised - g7 cup stayed in and the dm liner was revised to a freedom constrained liner and head.It was noted during revision it looked like the repair of the external rotators of the hip had failed some time ago.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).D10: 00801802803 femoral head sterile product do not resterilize 12/14 taper lot number is 64730408.G2: foreign: australia.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified the explanted bearing covered in bio-debris, with some scratching noted to the outer spherical surface.No further evaluation can be made from the provided picture.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: right total hip arthroplasty with evidence of leg length discrepancy on the initial image and posterior and superior dislocation of the right femoral head on the second image.A definitive root cause cannot be determined.It was noted the patient fell leading to the dislocation, however the reason for the fall is unknown 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: ACT ARTIC E1 HIP BRG 28X40MM
• Common Device Name: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18168807
• Report Number: 0001825034-2023-02665
• Device Sequence Number: 5541085
• Product Code: LPH
• UDI-Device Identifier: 00880304485037
• UDI-Public: (01)00880304485037(17)251002(10)789500
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• 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): 02/29/2024

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: Lay User/Patient
• Device Expiration Date: 10/02/2025
• Device Model Number: N/A
• Device Catalogue Number: EP-200146
• Device Lot Number: 789500
• 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: 10/25/2023
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2020
• 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: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female