MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LG HYBRID GLENOID 4MM TRIAL PT TRIAL PT; PROSTHESIS SHOULDER

Model Number N/A

Device Problem Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent a tsa and during the procedure a post of the trial broke.After preparing for the glenoid, the surgeon impacted the modular hybrid glenoid base and regenerex trial and determined it was ready for implantation.When he removed the glenoid trial, the inferior right peripheral post broke off the trial and was in the patient's glenoid.He was able to remove the peripheral peg by drilling into it using the hybrid glenoid straight shank drill and pulling the peg out.Then he proceeded as normal.

Manufacturer Narrative

(b)(4).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.

Event Description

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

Manufacturer Narrative

(b)(4).Reported event was confirmed as visual examination of the returned product found that the post was fractured and the device had signs of repeated use.Also, the sem analysis found that surface artifacts of the fracture site suggest an overload fracture.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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: LG HYBRID GLENOID 4MM TRIAL PT TRIAL PT
• Type of Device: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11094853
• MDR Text Key: 224434505
• Report Number: 0001825034-2020-04392
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 406194
• Device Lot Number: 270170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1