MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MACKAY RT PM MINI RVS GLENOID; PROSTHESIS,SHOULDER

Model Number N/A

Device Problems Component Missing (2306); Defective Device (2588)

Patient Problem No Code Available (3191)

Event Date 08/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).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 pmi was different to the designed implant and the psi guide.The design and psi guides had an anterior flange to assist in rotational stability, whilst the pmi implant was missing this and therefore different to what had been planned and prepared for.The event caused a delay of 35 minutes.Comprehensive reverse vrs was used to complete the procedure.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Reported event was confirmed by review of device history records.It was found that the incorrect model was mistakenly used for manufacturing preparations of the implant but the correct model file was used for manufacturing preparations of the implant model.The root cause of the reported issue is attributed to manufacturing deficiency as the incorrect model file (ie.Without anterior flange) was mistakenly used for manufacturing preparations for the implant, and the correct model file (ie.With anterior flange) was used for manufacturing preparations of the implant model.A summary of the investigation has been sent to the complainant.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: MACKAY RT PM MINI RVS GLENOID
• Type of Device: PROSTHESIS,SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8956174
• MDR Text Key: 156325717
• Report Number: 0001825034-2019-03920
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PM0002257
• Device Lot Number: 676750
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/08/2019
• Initial Date FDA Received: 09/03/2019
• Supplement Dates Manufacturer Received: 01/29/2020
• Supplement Dates FDA Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 86