MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON STD TRIAL; PROSTHESIS, HIP INSTRUMENT

Catalog Number 31-301303

Device Problem Difficult or Delayed Separation (4044)

Patient Problem No Information (3190)

Event Date 07/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 22-300920 lot 261390 arcos sts 20x190 mm, 31-301303 lot 199930 arcos cone trial c std 60 mm, 31-301852 lot 170201 hex drive 3,5 mm, 31-301852 lot 120701 hex drive 3,5 mm.Report source: (b)(6).Multiple mdr's were filed for this event: 0001825034 - 2019 - 03359, 0001825034 - 2019 - 03267, 0001825034 - 2019 - 03360, 0001825034 - 2019 - 03361, 0001825034 - 2019 - 03363.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

After implanting an arcos sts stem the trial cone body was locked on the stem in accordance with the surgical technique.When trying to unlock the trial cone body, the screwdriver broke inside the patient.The stem and trial body was explanted, and an attempt to disengage the trial body was made with a new screwdriver, which also broke.The third attempt yielded another broken driver.A surgical delay of 60 minutes was reported.No further information is available at the time of this reporting.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Examination of the returned device confirms the reported material fracture and wear.Review of device history record did not identify any related manufacturing deviations or anomalies that would have contributed to the reported event.The analysis confirms the device and it¿s materials are conforming to specifications.Root cause is unable to be determined at this time.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 information is available at the time of this reporting.

• Brand Name: ARCOS CON STD TRIAL
• Type of Device: PROSTHESIS, HIP INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8850110
• MDR Text Key: 152913418
• Report Number: 0001825034-2019-03267
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K100469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 31-301303
• Device Lot Number: 199930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/05/2019
• Initial Date FDA Received: 08/01/2019
• Supplement Dates Manufacturer Received: 10/25/2019
• Supplement Dates FDA Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention