MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SM HYBRID GLENOID BASE 4MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES

Model Number	113952
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Osteolysis (2377); Muscle/Tendon Damage (4532)
Date of Event	05/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was being considered for a revision surgery due to failure of their subscapularis that lead to the patient's gleno humeral joint unstable.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-00842-2.Medical products: item#: 113044, versa-dial 46x21x50 hum head; lot#: j7089153.Item#: pt-113950, pt hybrid glen post regenerex; lot#: 964350.Item#: 113631, comp primary stem 11mm mini; lot#: 65025650.Item#: 118001, versa-dial/comp ti std taper, lot#: 465650.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.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: significant findings include joint instability due to the apparent osteolysis and suspected glenoid implant loosening.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.

• Brand Name: SM HYBRID GLENOID BASE 4MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15258389
• Report Number: 0001825034-2022-01884
• Device Sequence Number: 14889374
• Product Code: MBF
• UDI-Device Identifier: 00880304462625
• UDI-Public: (01)00880304462625(17)241111(10)992960
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K193038
• 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
• Report Date (Section B): 08/19/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2024
• Device Model Number: 113952
• Device Catalogue Number: 113952
• Device Lot Number: 992960
• 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: 08/11/2022
• Initial Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2019
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female