MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CR 40MM GLENOSPHERE +3MM COCR; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Model Number	N/A
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent a revision procedure approximately seven months post implantation due to pain and disassociation of the glenosphere from the baseplate of their left shoulder.A new augmented baseplate, glenosphere/tray/poly were implanted.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
(b)(4).Medical products: item#: 010000589, comp rvrs 25mm bsplt ha+adptr; lot#: 633840.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).Medical products: item#: 010000589, comp rvrs 25mm bsplt ha+adptr; lot#: 633840.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported patient underwent a revision procedure approximately seven months post implantation due to pain and disassociation of the glenosphere from the baseplate of their left shoulder.A new augmented baseplate, glenosphere/tray/poly were implanted.Attempts to obtain additional information have been made; however, no more is available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay corrected information.The following sections were updated: b4; b5; g3; g6; h1; h2.Upon reassessment of the reported event, it was determined to be not reportable.The initial mfr report was forwarded in error and should be voided.The disassociation reported does not involve the reported implant, item#: 110030777, cr 40mm glenosphere +3mm cocr; lot#: 64328699.

• Brand Name: CR 40MM GLENOSPHERE +3MM COCR
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
• 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: 13560497
• Report Number: 0001822565-2022-00500
• Device Sequence Number: 19780404
• Product Code: KWS
• UDI-Device Identifier: 00887868231261
• UDI-Public: (01)00887868231261(17)290731(10)64328699
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 03/09/2022

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 Model Number: N/A
• Device Catalogue Number: 110030777
• Device Lot Number: 64328699
• 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: 01/25/2022
• Supplement Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 88 KG