MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ACT ARTIC E1 HIP BRG 28X42MM; PROSTHESIS, HIP

Catalog Number	EP-200148
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cmp (b)(4) d10: cat #: 110024463 / g7 dual mobility liner 42mm e / lot #: 536020.G2: australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported a patient underwent a right hip revision approximately two months post implantation due to a dislocation.The head and liner were removed and replaced.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.D10: cat #: 802202803/ femoral head 12/14 taper 28 mm diameter +3.5 mm neck length / lot #: 3196302.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-03420, 0001825034-2024-02550.Visual examination of the provided pictures identified the explanted head, bearing, and liner covered in bio-debris.The metal liner rim is deformed likely from explant.No further evaluation can be made.The complaint cannot be confirmed.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.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: ACT ARTIC E1 HIP BRG 28X42MM
• Common Device Name: PROSTHESIS, 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: 20668305
• Report Number: 0001825034-2024-02665
• Device Sequence Number: 7285673
• Product Code: JDI
• UDI-Device Identifier: 00880304485044
• UDI-Public: (01)00880304485044(17)290104(10)66328403
• 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: 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
• Report Date (Section B): 01/24/2025

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: Health Professional
• Device Catalogue Number: EP-200148
• Device Lot Number: 66328403
• 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: 11/07/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2024
• 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; SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female