MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ACT ARTIC E1 HIP BRG 28X40MM PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Ossification (1428); Pain (1994); Scar Tissue (2060); Joint Dislocation (2374)

Event Date 12/03/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4). 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 3500a will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2019 -05735, 0001825034 -2019 -05737.

Event Description

It was reported the patient underwent right tha. Subsequently, patient suffered a dislocation approximately 8 months later and was treated with unsuccessful closed reduction. Right revision was performed 2 days later due to the dual mobility bearing had dissociated from the biolox head. Extensive scar tissue, heterotopic ossification surrounding acetabulum component was noted. Difficulty with seating of head/liner, removed and performed additional debridement and was able to place liner and reduce hip without further issues. Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: ACT ARTIC E1 HIP BRG 28X40MM
• 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: 9519317
• MDR Text Key: 173163883
• Report Number: 0001825034-2019-05736
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: EP-200146
• Device Lot Number: 820680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 04/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2018
• 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 Treatment Data

Date Received: 12/26/2019 Patient Sequence Number: 1