MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ACT ARTIC E1 HIP BRG 22X36MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 04/14/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source foreign: source: (b)(6).Concomitant medical products: catalog number: 110010241, lot number: 6297939, brand name: g7 osseoti46mm ltd b, catalog number:110024460, lot number: 707400, brand name: g7 dm metal liner 36mm b, catalog number: 00771301000, lot number: 63958381, brand name: ml taper kinectiv size10, catalog number: 00784801200, lot number: 63958196, brand name: modular neck size e, catalog number: 00801802202, lot number: 63904959, brand name: cocr head +0x22mm, catalog number:010000991, lot number: 602010, brand name: e1aa brg 36mm id22mm.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 hip dislocation and disassociation of the head and bearing approximately 4 years post implantation.Attempts have been made and additional information on the reported event is unavailable.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, h1, h2, h3, h6, h10 visual examination of the provided pictures identified the bearing/head and stem with the bearing showing damage to the outside radius, is unknown if that damage was caused invivo or during extraction of the device.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: interval dislocation of the right hip arthroplasty reported event was confirmed by review of medical records provided.A review of the device history records identified no deviations or anomalies during manufacturing1.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.

• Brand Name: ACT ARTIC E1 HIP BRG 22X36MM
• 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: 14291658
• MDR Text Key: 291484177
• Report Number: 0001825034-2022-01133
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00880304527393
• UDI-Public: (01)00880304527393(17)230111(10)602010
• 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: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2023
• Device Model Number: N/A
• Device Catalogue Number: 010000991
• Device Lot Number: 602010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2018
• 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
• Patient Outcome(s): Required Intervention; Hospitalization