MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRABECULAR METAL REVERSE HUMERAL STEM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Fracture, Arm (2351)

Event Date 04/11/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: trabecular metal reverse poly liner pn00434903600 ln62368359, trabecular metal reverse glenosphere pn00434903611 ln62433467, trabecular metal baseplate pn00434901500 ln62453747.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent initial extremity procedure.Subsequently, open reduction was done for internal fixation of right periprosthetic fracture with grafting.

Manufacturer Narrative

(b)(4).Upon reassessment, it was identified that the reported event was caused by a patient fall and not zimmer biomet products.There was no alleged deficiency of the product.Previously submitted report should be voided.

• Brand Name: TRABECULAR METAL REVERSE HUMERAL STEM
• Type of Device: PROSTHESIS, SHOULDER
• 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: 7258733
• MDR Text Key: 99595485
• Report Number: 0001822565-2018-00677
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK052906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/26/2018

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?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 00434901213
• Device Lot Number: 62483751
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2018
• Initial Date FDA Received: 02/09/2018
• Supplement Dates Manufacturer Received: 03/26/2018
• Supplement Dates FDA Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2013
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 68