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

Model Number N/A

Device Problems Difficult to Insert (1316); Physical Resistance/Sticking (4012)

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

Event Date 08/24/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02615.

Event Description

It was reported that the cone body trial was having difficulty attaching to the stem.The screw locking mechanism was not catching.It did eventually lock down.When we went to unlock the screw after trialing, the screw would not loosen.When loosened, tip of driver broke.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

A cone body trial was returned and evaluated.There was no visible damage to the taper, however, shows signs of usage.Review of the device history records identified no (related) deviations or anomalies during manufacturing medical records were not provided.A definitive root cause could not 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 TRL
• Type of Device: PROSTHETIC, 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: 12448026
• MDR Text Key: 270609068
• Report Number: 0001825034-2021-02616
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304489998
• UDI-Public: (01)00880304489998(11)150814(10)427427
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 31-301312
• Device Lot Number: 427427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/09/2021
• Supplement Dates Manufacturer Received: 01/06/2022
• Supplement Dates FDA Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Male