MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ACT ARTIC E1 HIP BRG 28X50MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 110024466 ¿ g7 dual mobility liner ¿ 993780 128-828/03 ¿ link head - 200116/0155 110010249 ¿ g7 shell ¿ 7224619 00625006535 ¿ bone screw ¿ j7119201 00625006515 ¿ bone screw - j6937387 00625006535 ¿ bone screw - j6921460 unknown link stem ¿ unknown part and lot report source australia radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: there is abnormal alignment of the hip arthroplasty with lateral position of the prosthetic femoral head within the cup.On the 2 coronal ct images, there is displacement of the inner bearing into the adjacent soft tissues.There is no fracture.Visual examination of the provided pictures identified the bearing has no visible damage.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.It is noted that zimmer biomet products were used in conjunction with a competitor device.Zimmer biomet has not confirmed the compatibility of the reported combination of devices, and these would be considered off-label usages.However, it cannot be confirmed that the combination of the link and zimmer biomet products caused or contributed to the reported event.A summary of the investigation has been sent to the customer.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 00852.
Event or Problem Description
It was reported that patient underwent a revision of competitor product after an unknown amount of time post implantation due to periprosthetic fracture and recurring dislocations.Subsequently, the patient experienced a dislocation approximately 3 months post revision.Patient was taken to the emergency department where relation was attempted.During x-ray review, it was found that the dual mobility bearing had disassociated from the competitor head component.The patient therefore, underwent a revision surgery where a new head and liner were placed, the shell and stem remain implanted.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: ACT ARTIC E1 HIP BRG 28X50MM
• 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: 16775904
• Report Number: 0001825034-2023-00853
• Device Sequence Number: 20579801
• Product Code: LPH
• UDI-Device Identifier: 00880304703544
• UDI-Public: (01)00880304703544(17)310908(10)993780
• 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: 2022
• 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
• Report Date (Section B): 04/19/2023

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: EP-200156
• Device Lot Number: 798960
• 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: 01/27/2023
• Initial Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2021
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown