MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR RVS GLENO 2-PRNG INS/IMP; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 110028879

Device Problem Fracture (1260)

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

Event Date 09/20/2023

Event Type  malfunction  

Event Description

It was reported that during a reverse shoulder arthroplasty performed approximately three (3) weeks ago, two separate 2-prong glenosphere impactor/inserter holders fractured when attempting to be impacted into place with a metal mallet.The procedure was completed using a third glenosphere implant holder.The patient retained no foreign bodies and there were no reported consequences as a result of this malfunction.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event; please see the associated report: 0001825034-2023-02372.D10: item number: 110028879 lot number: 803760 e1: full establishment name - thunder bay regional health sciences centre g2: foreign - the event occurred in canada the customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that 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.The product has been received and is being evaluated 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 which would change or alter any conclusions or information, a supplemental report 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.The following sections were updated/corrected: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6.The reported event is confirmed for 1 (one) impactor but not the other.Only 1 (one) fractured pad was returned, and the provided picture is not clear enough to determine if both pads broke.Visual examination of the returned product/provided pictures identified both items show signs of use with gouges on the strike plate.Lot number 250250 was returned with some residual poly on the threads for the inserter end cap.There was also one piece of the black poly inserter end cap returned.Unable to identify which inserter it belongs.The picture provided showed 2 (two) pads, but it wasn't clear if both were broken.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.If any further information 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 is available at the time of this report.

• Brand Name: COMPR RVS GLENO 2-PRNG INS/IMP
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 17940284
• MDR Text Key: 325742839
• Report Number: 0001825034-2023-02373
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00880304731394
• UDI-Public: (01)00880304731394(11)190315(10)250250
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K193373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2024

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 Catalogue Number: 110028879
• Device Lot Number: 250250
• 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: 09/21/2023
• Initial Date FDA Received: 10/16/2023
• Supplement Dates Manufacturer Received: 10/23/2023; 01/08/2024
• Supplement Dates FDA Received: 11/03/2023; 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10.
• Patient Sex: Prefer Not To Disclose