MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ACT ARTIC E1 HIP BRG 28X38MM S44 DIA28; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).Concomitant medical products: catalog number: ep-200144; lot number: 926670; brand name: act artic e1 hip brg.Catalog number: 650-1055; lot number: 2020060247; brand name: cer bioloxd option hd.Catalog number: 650-1064; lot number: 2997131; brand name: cer option type 1 tpr.Catalog number: 51-102070; lot number: 6663490; brand name: tprlc xr fp type1 pps.Catalog number: 110010262; lot number: 110010262; brand name: g7 osseoti multihole 48mm.Catalog number: 110024461; lot number: 814540; brand name: g7 dual mobility liner.Multiple reports were reported along with this report 0001825034-2022-00795.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 that the patient was revised due to dislocation approximately 1 year post implantation.Attempts have been made and additional information on the reported event is unavailable.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were visual examination of the provided pictures identified the bearing is deformed on the outer lip and has scratching.The femoral head has black discoloration on one side.Complaint sample was evaluated and the reported event was not confirmed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Root cause could not 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
It was reported that the patient was revised due to disassociation of the head and bearing approximately 1 year post implantation.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: ACT ARTIC E1 HIP BRG 28X38MM S44 DIA28
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13977642
• Report Number: 0001825034-2022-00711
• Device Sequence Number: 5555086
• Product Code: KWY
• UDI-Device Identifier: 00880304485020
• UDI-Public: (01)00880304485020(17)250624(10)926670
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 05/20/2022

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: 06/24/2025
• Device Model Number: N/A
• Device Catalogue Number: EP-200144
• Device Lot Number: 926670
• 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: 03/08/2022
• Supplement Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2020
• 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: Required Intervention; Hospitalization
• Patient Sex: Female