MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ACT ARTIC E1 HIP BRG 28X46MM; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had multiple dislocations post acetabular revisions to the g7 dm.The patient had dislocated and returned to the er where an intraprosthetic dislocation post closed reduction was found.Subsequently, the patient was revised four years post implantation to a freedom cup.
Additional Manufacturer Narrative
(b)(4) 110024465 g7 dual mobility liner 46mm g 525850.00877702804 biolox⮠option, head, xl, 㸠28/+7, taper 12/14 2909484.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 02057.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
Visual examination of the provided pictures identified the bearing, liner, and ceramic head all explanted and covered in bio-debris.The head shows scratching/metal transfer.No further evaluation can be made from the provided picture.Review of the device history records identified no deviations or anomalies during manufacturing.One undated x-ray assessed and not submitted to mmi, as the phase of care the image was taken, is unable to be determined.A definitive root cause could not be determined.This complaint cannot be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report 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 28X46MM
• Common Device Name: PROTHESIS, 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: 17664770
• Report Number: 0001825034-2023-02059
• Device Sequence Number: 6994018
• Product Code: LPH
• UDI-Device Identifier: 00880304485068
• UDI-Public: (01)00880304485068(17)240515(10)886620
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K161190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

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: 05/15/2024
• Device Model Number: N/A
• Device Catalogue Number: EP-200152
• Device Lot Number: 886620
• 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: 08/08/2023
• Supplement Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2019
• 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
• 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 Age: 78 YR
• Patient Sex: Female