MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ACT ARTIC E1 HIP BRG 28X42MM; PROSTHESIS, HIP

Catalog Number EP-200148

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

Patient Problem Bone Fracture(s) (1870)

Event Date 03/31/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: cat #: 00801802803 / femoral head sterile product do not resterilize 12/14 taper / lot #: 64719808.Unknown liner.G2: australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Event Description

It was reported a patient underwent a hip revision approximately three years post implantation due to a disassociation and fracture after experiencing a fall.The head and bearing were removed and replaced.Attempts have been made and no further information is available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Event Description

No additional event information to report at this time.

• Brand Name: ACT ARTIC E1 HIP BRG 28X42MM
• Type of Device: 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: 19191103
• MDR Text Key: 341138556
• Report Number: 0001825034-2024-01082
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00880304485044
• UDI-Public: (01)00880304485044(17)280108(10)620190
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 05/29/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: EP-200148
• Device Lot Number: 620190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/31/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H11 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 60 KG