MAUDE Adverse Event Report: . ACT ARTIC HD; PROSTESIS, HIP

Catalog Number XL-200150

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

Patient Problems Hematoma (1884); Joint Dislocation (2374)

Event Date 09/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item# 110024464/ g7 dual mobility liner/ lot #535710, item# 650-1067/ tpr sleve/ lot # 2959184, item # 650-1055/ cer bioloxd hd/lot # 2957937.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 05493.

Event Description

It was reported patient underwent hip revision approximately 2 months post implantation due to dislocation during attempts to relocate the hip, the active articulation head and the femoral head came apart and would not relocate.G7 duel mobility implant was replace with g7 hi-wall liner.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Product has been received by zimmer biomet and the investigation is complete.Reported event was confirmed by review of x-rays.Radiographs indicated intra-prosthetic dislocation (disassociation).Dhr was reviewed and no discrepancies relevant to the reported event were found root cause was unable to 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

Hematoma was noted during revision and was evacuated.No additional information is available.

Event Description

No additional information available at this time.

• Brand Name: ACT ARTIC HD
• Type of Device: PROSTESIS, HIP
• Manufacturer (Section D): .; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9447253
• MDR Text Key: 170307807
• Report Number: 0001825034-2019-05494
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K110555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: XL-200150
• Device Lot Number: 473080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 93