MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 25MM COMP REV GLEN BSPLT REAMR; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/23/2023

Event Type  malfunction  

Event Description

It was reported that while reaming for the mini baseplate, the surgeon mentioned that the reamer was extremely blunt.No adverse event has been reported as a result of the malfunction.No further information is available.

Manufacturer Narrative

(b)(4).Proposed component code: mechanical (g04) - drill.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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.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 is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04) - drill.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified wear on the ao connect end.The reamers cutting edges are not sharp and have damage to every cutting edge.Device history record (dhr) was reviewed and no discrepancies were found.The reported event is confirmed as the product was returned.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 is available at the time of this report.

• Brand Name: 25MM COMP REV GLEN BSPLT REAMR
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16692623
• MDR Text Key: 312875518
• Report Number: 0001825034-2023-00669
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00880304731523
• UDI-Public: (01)00880304731523(11)170926(10)128150
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• 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: 110029136
• Device Lot Number: 128150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2017
• 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 Age: 79 YR
• Patient Sex: Female