MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ B HI 60MM; PROSTHESIS HIP

Catalog Number 11-301312

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

Patient Problems Fall (1848); Failure of Implant (1924); Joint Dislocation (2374)

Event Date 02/09/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical devices: part # unknown / unknown stem/ lot # unknown; part #unknown / unknown head/ lot # unknown; part #unknown / unknown liner/ lot # unknown; part #unknown / unknown screw/ lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 -00605.

Event Description

It was reported that patient was revised one-year post implantation due to a fall causing dislocation.During the revision it was discovered the taper junction between the arocs cone body and stem was not engaged.However, the set screw was found to be in place.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.Device history record (dhr) was reviewed and no discrepancies 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

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

• Brand Name: ARCOS CON SZ B HI 60MM
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11420823
• MDR Text Key: 234905574
• Report Number: 0001825034-2021-00604
• Device Sequence Number: 1
• Product Code: MAY
• UDI-Device Identifier: 00880304474093
• UDI-Public: (01)00880304474093(17)030212(01)267450
• Combination Product (y/n): N
• PMA/PMN Number: K090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11-301312
• Device Lot Number: 267450
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention