MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 5.0 MM DIAMETER CORTICAL SCREW SHOULDER, PROSTHESIS

Model Number 47-2484-045-50

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 01/21/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4). Concomitant medical devices: 5. 0 mm diameter cortical screw cat: 47248404050 lot: 64677063; 6. 0 mm diameter cancellous screw cat: 47248405060 lot: 64466394; greater trochanter femoral nail cat: 47249232011 lot: 62451700. Foreign: (b)(6). Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up report will be submitted.

Event Description

It was reported that approximately 8 months post implantation, the patient experienced a fracture and the implanted nail had also fractured and become loose. The patient was revised. No further information has been provided.

• Brand Name: 5.0 MM DIAMETER CORTICAL SCREW
• Type of Device: SHOULDER, PROSTHESIS
• 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: 11313428
• MDR Text Key: 231352778
• Report Number: 0001822565-2021-00370
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K082770
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 47-2484-045-50
• Device Catalogue Number: 47248404550
• Device Lot Number: 64581106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 06/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2019
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/11/2021 Patient Sequence Number: 1