MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VERSA-DIAL 46X21X50 HEAD PROV; TEMPLATE

Model Number N/A

Device Problem Device Contamination With Biological Material (2908)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.This report is number 18 of 23 mdrs filed for the same patient (reference 1825034-2017-00668 - 00689 and 1825034-2016-04742).

Event Description

During a shoulder arthroplasty, contaminate was found under the metal plate on the back of the humeral trial heads.After the procedure, all the trials were then taken apart, decontaminated again, reassembled to be used for the next case that was postponed by two hours for this second decontamination of the trials.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Device history records were reviewed and no discrepancies were found.Product was visually examined.Externally, the products do not appear to have any bioburden on the head or plate.To further investigate, several provisionals (both versadial and comprehensive) were disassembled.Upon disassembly, there was notable staining indicative of bioburden under the plate; therefore, the complaint is confirmed.Investigation results concluded that the root cause of the complaint is a design related issue.A design change has been initiated to address the reported event.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: VERSA-DIAL 46X21X50 HEAD PROV
• Type of Device: TEMPLATE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6331696
• MDR Text Key: 67500480
• Report Number: 0001825034-2017-00685
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 407244
• Device Lot Number: 882090
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2009
• 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