MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 16X200MM INTLKNG DIST; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/26/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: cat# 31-301000 arcos proximal body inserter lot#unk, cat# 31-301857 arcos taper disasmbly 60mm lot#unk.Foreign country: (b)(6).The device will not be returned for analysis, as the device remains implanted; 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: 0001825034-2021-02682.

Event Description

It was reported that a patient underwent an initial surgery on an unknown date with non zimmer biomet products.A g7 dual mobility with arcos ils 200 stem and cone body proximal were used for the revision.When attaching the proximal and distal part of the arcos, the proximal part was attached to the 31-301000 proximal body inserter tool, then it was hammered down on the cone on the ils stem.The surgeon then tried to assemble the screw between the proximal and distal part, but it didn¿t take the treads.The surgeon then used more force to try to hammer down the proximal part so that the treads would take hold, but still the screw didn¿t make it down to the distal ils stem.The surgeon then tried to disassemble the proximal part from the stem with 31-301857 60 mm disassembly tool.But after using massive force, it was decided that the tool was on the breaking point, and the surgeon didn¿t want to risk it.Then he tried the 31-302006+ 31-302001+ 31-302004 assembly tool, in the hope that the taper would engage more so the screw would engage the treads, but still after delivering the appropriate amount of pressure with the torque wrench, the screw was still not engaging.It was decided that the taper was so firmly engaged that it wouldn¿t come apart.The surgeon considered starting all over, but decided removing the implant would be more harmful for the patient than to go on without the screw.There was a 30-45 minute delay.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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: ARCOS 16X200MM INTLKNG DIST
• 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: 12495155
• MDR Text Key: 272148202
• Report Number: 0001825034-2021-02681
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K100469
• 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: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-301816
• Device Lot Number: 195630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1