MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP AUG MINI BSPLT W TPR MD; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	110032420
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Bone Fracture(s) (1870)
Date of Event	08/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Fda product code - phx.Concomitantmedical products: item# 110031399; lot# 65255109, item# 110030776; lot# 65323728, item# 110031428; lot# 65163940, item# 20809000402; lot# 65351090.Report source: foreign - event occured in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was discarded by the hospital as a biohazard.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 during an initial implantation, the surgeon fractured the anterior cortex of the patient's glenoid.Subsequently, the surgeon opted to leave the patient's joint loose in order to allow the bone to heal with the intention of revising the patient at a later time to re-tension the shoulder.The patient was revised approximately two (2) months later, where a new glenosphere and humeral poly were also exchanged to provide additional stability.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
Additional information received that noted the bone fracture occurred while the reamer was being used and prior to baseplate implantation.The initial report for the baseplate should be voided and this event will be reported under mfr report# 0001825034-2022-02378.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: COMP AUG MINI BSPLT W TPR MD
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 15598777
• Report Number: 0001825034-2022-02317
• Device Sequence Number: 2136306
• Product Code: PHX
• UDI-Device Identifier: 00880304993242
• UDI-Public: (01)00880304993242(17)260816(10)65212354
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 10/20/2022

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: 08/16/2026
• Device Catalogue Number: 110032420
• Device Lot Number: 65212354
• 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: 10/10/2022
• Supplement Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female