MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL BEARING TRIAL 44STD-41STD; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Foreign Body In Patient (2687); No Information (3190)

Event Date 02/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a reverse total shoulder arthroplasty.During trialing it was reported that the humeral bearing trial stem broke upon attempting to remove from trial stem.The fractured pieces fell into the wound and all were successfully retrieved.The trialing had been completed, therefore no other item was needed to complete the procedure.No patient impact was reported.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by visual inspection and it is noted the post has fractured off of the humeral trial; the product was submitted for fracture analysis.Per the analysis, the fracture surface artifacts suggest bending overload fracture.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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.

• Brand Name: HUMERAL BEARING TRIAL 44STD-41STD
• 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: 7328866
• MDR Text Key: 102070864
• Report Number: 0001825034-2018-01510
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080642
• 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: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: BSS1002419
• Device Lot Number: W16-01574
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR