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

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2021

Event Type  Injury  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 288600280
• Report Number: 0001825034-2022-00711
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00880304485020
• UDI-Public: (01)00880304485020(17)250624(10)926670
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161190
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female