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

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Hematoma (1884); Failure of Implant (1924); Pain (1994); Joint Dislocation (2374); Metal Related Pathology (4530); Unequal Limb Length (4534)
Date of Event	07/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent a hip revision approximately 5 years post implantation due to a dislocation.The head and liner were replaced.No additional information.
Additional Manufacturer Narrative
(b)(4).Cat# 650-1055 lot# 2886422 delta ceramic option head, cat# 650-1067 lot# 2900844 cer option type 1 tpr sleve, cat# ep-200152 lot# 038300 act artic e1 hip brg 28x46mm s52 dia28.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the patient underwent a left hip revision approximately 2 months post implantation due to dislocation, pain, leg length discrepancy and dissociation.During the revision the polyethylene was in the posterior soft tissues completely dissociated from the inner ceramic head and once head removed noted minimal trunnionosis.The acetabular liner and head were exchanged without complications.No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: a4, b4, b5, b7, d1, d2, d4, g3, g4, h2, h3, h6.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected complaint sample was evaluated and the reported event was confirmed.One g7 dual mobility liner 46mm g, delta ceramic option head dia2 8, cer option type 1 tpr sleve +3 pe 1, and act artic e1 hip brg 28x46mm s52 dia28 was returned and evaluated.Upon visual inspection the ceramic head had wear to the outer radius.The returned liner had lip damage and scuffing on the inner radius.The taper has lip damage.The poly liner has lip damage and indentations on the outside radius.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: superior dislocation of the femoral component with respect to the cup, eccentric positioning of the femoral head component within the cup.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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 further event information available at the time of this report.

• Brand Name: ACT ARTIC E1 HIP BRG 28X46MM
• 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: 15165314
• Report Number: 0001825034-2022-01793
• Device Sequence Number: 2123478
• Product Code: LPH
• UDI-Device Identifier: 00880304485068
• UDI-Public: (01)00880304485068(17)220622(10)038300
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K161190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/07/2022

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 Expiration Date: 06/22/2022
• Device Model Number: N/A
• Device Catalogue Number: EP-200152
• Device Lot Number: 038300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2022
• 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: 07/14/2022
• Supplement Date Received by Manufacturer: 08/31/2022; 09/21/2022; 10/18/2022; 10/31/2022
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 09/02/2022; 09/26/2022; 10/24/2022; 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/22/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 84 KG