MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 14MM ÿ 130MM LENGTH HUMERAL STEM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Model Number	00-4349-014-13
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-00752-1.Concomitant medical products: item#: 00434906603, 40mm +3mm offset 65 degree neck angle retentive poly liner; lot#: unknown.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.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.
Event or Problem Description
It was reported that the patient has undergone three (3) revisions due to the implants disassociating.The latest revision was approximately two (2) months after the second revision was performed.

• Brand Name: 14MM ÿ 130MM LENGTH HUMERAL STEM
• 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: 15322866
• Report Number: 0001822565-2022-02464
• Device Sequence Number: 12141993
• Product Code: KWS
• UDI-Device Identifier: 00889024268975
• UDI-Public: (01)00889024268975(17)310614(10)65102853
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K130661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/30/2022

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: 00-4349-014-13
• Device Catalogue Number: 00434901413
• Device Lot Number: 65102853
• 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: 08/04/2022
• Initial Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2021
• 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 Sex: Unknown