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

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 650-1064 cer option type 1 tpr sleve -6; lot number 2971089.650-1055 cer bioloxd option hd 28mm ; lot number 2958711.110024464 g7 dual mobility liner 44mm f ; lot number 870660.00625006530 bone scr 6.5x30 self-tap ; lot number 64531906.110010265 g7 osseoti multihole 54mm f ; lot number 6575098.51-103140 tprlc 133 t1 pps so 14x148mm; lot number 6537092.Ep-200150 act artic e1 hip brg 28x44mm ; lot number 885030.The product has been received by zimmer biomet.The investigation is currently in process.Once the investigation has been completed, a follow-up report will be submitted.
Event or Problem Description
It was reported that the patient underwent a revision procedure 3 years and 4 months post implantation due to a dislocation of the patient's dual mobility bearing and disassociated 28 head from the active articulation head.There is no additional information available at the time of this report.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.One bearing along with a ceramic head were returned and evaluated.Upon visual inspection the head shows scuffing on the od.The bearing has indentations and scuffing on the o.D.And damage to the lip of the device.A review of the device history records identified no related deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: left total hip arthroplasty with polyethylene wear of the acetabular component and possible dislocation.Overall sizing of the implant demonstrates small femoral head with possible poly wear of the left acetabular cup.Possible dislocation seen.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.

• Brand Name: ACT ARTIC E1 HIP BRG 28X44MM
• Common Device Name: PROSTHETIC, 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: 17207633
• Report Number: 0001825034-2023-01420
• Device Sequence Number: 5540138
• Product Code: LPH
• UDI-Device Identifier: 00880304485051
• UDI-Public: (01)00880304485051(17)241004(10)885030
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K161190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 10/11/2023

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: 10/04/2024
• Device Model Number: N/A
• Device Catalogue Number: EP-200150
• Device Lot Number: 885030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2023
• 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: 06/07/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2019
• 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: Unknown
• 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: PLEASE SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 155 KG