MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SM HYBRID GLENOID BASE 4MM; PROSTHESIS, SHOULDER

Catalog Number 113952

Device Problems Material Erosion (1214); Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Metal Related Pathology (4530)

Event Date 05/19/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent a revision procedure due to a disassociated post and glenoid which caused metallosis and wear.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Concomitant medical products: pt hybrid glen post regenerex, cat# pt-113950, lot#ni.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01330.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Part 113952: visual examination of the provided pictures identified the glenoid has a hole worn through it, and the articulating surface is worn in the form of nicks and scratches.One of the posts on the back of the poly is deformed and some bone cement can be visualized; however, it is unknown if this deformation happened in-vivo or during explanting.As the products have not returned further dimensional and visual analysis could not be performed.Part 113952: review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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.

Event Description

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

• Brand Name: SM HYBRID GLENOID BASE 4MM
• 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: 14573271
• MDR Text Key: 293152618
• Report Number: 0001825034-2022-01329
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00880304452625
• UDI-Public: (01)00880304452625(17)210115(10)576650
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2021
• Device Catalogue Number: 113952
• Device Lot Number: 576650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2016
• 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
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female