MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CUS MINI RVS GLENOID CONST; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Information (3190)

Event Date 03/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Concomitant medical products: pm0001559, sovak pm mini glenoid lt, lot 301290.Pm0001560, sovak bone model kit, lot 694820.Cp0001297, constrained glenoid liner, lot 468420.Cp0001298, const glenoid ring inserter, lot 468920.Event occurred in (b)(6).

Event Description

It was reported that during the patient's initial tsa with a custom device, the glenoid construct was unable to be assembled with the baseplate.This resulted in a delay in procedure greater than 30 minutes, and the surgeon was unable to finish the procedure.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Visual examination of the provided pictures identified the taper on the captured shell is too large and will not assemble to the custom baseplate.The complaint is confirmed.X-rays were received; however, they were not reviewed as the reported issue occurred intraoperatively.Dhr was reviewed and no discrepancies relevant to the reported event were found.The root cause was the incorrect print was utilized to program the cnc machine that was used.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.

Event Description

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

• Brand Name: CUS MINI RVS GLENOID CONST
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8499933
• MDR Text Key: 141479866
• Report Number: 0001825034-2019-01634
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• 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: CP0001296
• Device Lot Number: 844300
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention