MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM REVERSE STEM 12MM X 130MM; PROSTHESIS, SHOULDER

Model Number	00-4349-012-13
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision surgery approximately four years post initial due to disassociation of poly liner from the stem.The loose liner was explanted and a new poly liner was implanted.No other implants were revised.No additional patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: cat: 00434904006, lot: 62977613, 40mm poly liner plus 6mm ofs; cat: 00434901500, lot: 63715593, 15mm post length base plate; cat: 00434904011, lot: 63653808, tm reverse 40mm glenosphere; cat: 01.04223.036, lot: 2921546, invers/revers scr syst 4.5- 36; cat: 01.04223.036, lot: 2921529, invers/revers scr syst 4.5- 36.Foreign- (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-00233.
Additional Manufacturer Narrative
Reported event was confirmed by review of radiographs.Review of the available radiographs identified that left total shoulder reversed arthroplasty with possible loosening of the glenoid component with the associated changing orientation of the glenosphere as well as polyethylene wear of the glenohumeral component.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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 or Problem Description
No additional event information is available at the time of this report.

• Brand Name: TM REVERSE STEM 12MM X 130MM
• 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: 13368745
• Report Number: 0001822565-2022-00234
• Device Sequence Number: 3991787
• Product Code: KWT
• UDI-Device Identifier: 00889024268951
• UDI-Public: (01)00889024268951(17)270831(10)63700625
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K052906
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2022

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: 00-4349-012-13
• Device Catalogue Number: 00434901213
• Device Lot Number: 63700625
• 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: 01/17/2022
• Supplement Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2017
• 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: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 117 KG