MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 SCREW 6.5MM X 40MM; BONE SCREW

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091); Discomfort (2330); Sweating (2444)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 110010247, g7 osseoti 4 hole shell 58mm g, r3658948a, 010000999, g7 screw 6.5mm x 30mm, 3793823, 163666, 28mm dia cocr mod hd +12mm nk, 313010, ep-200152, act artic e1 hip brg 28x46mm, 137810, 110024465, g7 dual mobility liner 46mm g, 014690.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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

It was reported that the patient had a full revision procedure due to discomfort, swelling, night sweats with metallic odor, sciatic symptoms down the leg, a firm mass which caused mobility restrictions, and pain.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: G7 SCREW 6.5MM X 40MM
• Type of Device: BONE SCREW
• 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: 7404417
• MDR Text Key: 104662437
• Report Number: 0001825034-2018-02438
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010001001
• Device Lot Number: 3676807
• Other Device ID Number: (01)00880304527492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2015
• 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
• Patient Outcome(s): Hospitalization; Required Intervention