MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BEARING +3 MM THICKNESS 40 MM DIAMETER; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Model Number	110031428
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02637.Medical products: item#: 110031428, bearing +3 mm thickness 40 mm diameter; lot#: 65163939.Item#: 110031405, mini tray std cocr +6 offset; lot#: 65075707.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 that a patient was undergoing an initial shoulder arthroplasty.During implantation of the first implant, the polyethylene disassociated and was explanted.A second polyethylene implant was used and this implant disassociated as well.A third polyethylene implant was implanted and it was implanted successfully.There was no patient injury as a result of the malfunction.
Event or Problem Description
It was reported that this event was previously reported.The event was reported under mfr number 0001822565-2022-02574.Therefore, this initial medwatch was submitted in error and should be voided.
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 receiving additional information of the reported event, it was determined that the product was previously reported under this mfr number 0001822565-2022-02574.The initial report should be voided.

• Brand Name: BEARING +3 MM THICKNESS 40 MM DIAMETER
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15458142
• Report Number: 0001822565-2022-02709
• Device Sequence Number: 20543489
• Product Code: KWS
• UDI-Device Identifier: 00887868231599
• UDI-Public: (01)00887868231599(17)270105(10)65164152
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/09/2022

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
• Operator of Device: Health Professional
• Device Model Number: 110031428
• Device Catalogue Number: 110031428
• Device Lot Number: 65164152
• Was Device Available for Evaluation?: Yes
• 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: 08/24/2022
• Supplement Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2022
• 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
• Patient Sex: Male