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

Model Number 110031428

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 08/15/2022

Event Type  malfunction  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 304008169
• Report Number: 0001822565-2022-02709
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00887868231599
• UDI-Public: (01)00887868231599(17)270105(10)65164152
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181611
• 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: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Male