MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ACT ARTIC E1 HIP BRG 28X44MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a right hip revision due to the cocr liner disengaging from the g7 cup.Discussion with the surgeon on the day indicated a screw which wasn¿t sitting flush inside a screw hole of the cup was the probable cause of liner disengagement.No additional information.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: cat# 802202802 lot# 3089267 cocr head.Cat# 110024464 lot# 111570 g7 dual mobility liner.Report source: foreign: country: australia.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 02418.
Additional Manufacturer Narrative
Upon reassessment of the reported event, the bearing was determined to be not reportable as the device is not believed to have caused or contributed to the event.The initial report was forwarded in error and should be voided.
Event or Problem Description
Upon reassessment of the reported event, the bearing was determined to be not reportable as the device is not believed to have caused or contributed to the event.The initial report was forwarded in error and should be voided.

• Brand Name: ACT ARTIC E1 HIP BRG 28X44MM
• 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: 15667740
• Report Number: 0001825034-2022-02419
• Device Sequence Number: 7179295
• Product Code: LPH
• UDI-Device Identifier: 00880304485051
• UDI-Public: (01)00880304485051(17)270722(10)616880
• 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 Explanted Year: 2022
• 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): 12/07/2022

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: EP-200150
• Device Lot Number: 616880
• 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: 10/03/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2022
• 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
• 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
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic