MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP CNV GLEN BASE NON HA; PROSTHESIS, SHOULDER

Catalog Number	110005273
Medical Device Problem Codes	Material Erosion (1214); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	07/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Product code: phx.Concomitant products: comp conv glen liner e1 cat# 110005237 lot# 375420.Versa-dial 46x18x53 hum head cat# 113042 lot# 020990.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.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 - 2021 - 02457 , 0001825034 - 2021 - 02458.
Event or Problem Description
It was reported that a patient underwent a revision procedure approximately 30 months post implantation due to disassociation of the glenoid poly and baseplate.Metallosis occurred between the baseplate and humeral head due to the disassociation.Poly and humeral head were removed and patient was converted to reverse.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h10 visual inspection of the returned products to verify item and lot numbers.Inspection of each product found them to be damaged and worn.Lot 020990 has a been assembled with a component part (lot 118001).Wear marks and discoloration was found on lot 020990.Inspection of lot 375420 found the part to be fractured and not all the pieces were returned.There was also an unknown blue screw returned with a piece of poly still attached to it.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 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: COMP CNV GLEN BASE NON HA
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12408313
• Report Number: 0001825034-2021-02459
• Device Sequence Number: 4182178
• Product Code: PHX
• UDI-Device Identifier: 00880304568105
• UDI-Public: (01)00880304568105(17)280915(10)385170
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K130390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 110005273
• Device Lot Number: 385170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male