MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS TRAY CO 44MM; PROSTHESIS, SHOULDER

Model Number 115370

Device Problems Positioning Failure (1158); Material Deformation (2976)

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

Event Date 02/09/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Common device name: product code: phx.Report source: foreign: germany.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.

Event Description

It was reported that during an initial shoulder replacement surgery, the locking ring of the humeral shell was closed or compressed, rendering it unable to assemble with the polyethylene bearing.A second set of implants was used to complete the procedure.No patient impact or adverse events have been reported as a result of this malfunction.Due diligence is in process for this event; to date no further information has been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product verified the lot number and identified the device shows minimal signs of use with some small nicks or gouges on the locking ring.The locking ring was not compressed or closed when received.Device history record was reviewed and no discrepancies related to the reported event were found.Investigation results concluded that the reported event was due to use error.It was reported that the bearing assembly tool was not utilized while trying to mate the tray and bearing during the procedure.Per the surgical technique, "utilize the bearing assembly tool to first spread the locking mechanism to the open position by fully seating the bearing assembly tool on the humeral tray.An audible ¿click¿ will be heard when the bearing assembly tool is properly engaged.Next, place the engaged bearing assembly tool and humeral tray on the glenosphere offset orientation block.Position the definitive humeral bearing in the definitive humeral tray, ensuring that the laser etching on the bearing aligns with the laser etching on the humeral tray.Using the humeral bearing/tray impactor tool, apply downward pressure to the bearing and remove the bearing assembly tool continuing to apply downward pressure on the bearing." a summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.If any information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information at time of this report.

• Brand Name: COMP RVS TRAY CO 44MM
• 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: 16573758
• MDR Text Key: 312230582
• Report Number: 0001825034-2023-00536
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00880304543201
• UDI-Public: (01)00880304543201(17)320620(10)354300
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K113069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 115370
• Device Catalogue Number: 115370
• Device Lot Number: 354300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/03/2023
• Initial Date FDA Received: 03/20/2023
• Supplement Dates Manufacturer Received: 07/20/2023
• Supplement Dates FDA Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose