MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 18X190MM SPL TPR DIST HA; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult to Insert (1316); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2015

Event Type  malfunction  

Manufacturer Narrative

Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to product being misplaced at hospital.Dhr was reviewed and no discrepancies were found.The complaint was not confirmed.The 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.(b)(4).

Event Description

It was reported that patient underwent initial hip arthroplasty on an unknown date in which competitor products were used to complete the procedure.Subsequently, the patient was revised to biomet products on (b)(6) 2015.During the procedure, the locking screw from the top of the stem was being used to screw the proximal body onto the stem, but the screw would not engage within the proximal body.The surgeon felt that the 3.5 mm screwdriver being used was not able to engage to top of the screw as the hex shape on the screw was not compatible with the screwdriver and that is why it was not gaining any torque.A new screw was used with the same screwdriver to complete the procedure.No adverse events have been reported as a result of the malfunction.

• Brand Name: ARCOS 18X190MM SPL TPR DIST HA
• 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: 6904244
• MDR Text Key: 87877804
• Report Number: 0001825034-2017-07451
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK100469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2017

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 Expiration Date: 09/11/2023
• Device Model Number: N/A
• Device Catalogue Number: 22-300918
• Device Lot Number: 387740
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2015
• Initial Date FDA Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1