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

Catalog Number 110032420

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Bone Fracture(s) (1870)

Event Date 08/19/2022

Event Type  Injury  

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 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.

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 Description

No further event information available at the time of this report.

• Brand Name: COMP AUG MINI BSPLT W TPR MD
• Type of Device: 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
• MDR Text Key: 301722813
• Report Number: 0001825034-2022-02317
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00880304993242
• UDI-Public: (01)00880304993242(17)260816(10)65212354
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K172502
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 10/10/2022
• Initial Date FDA Received: 10/13/2022
• Supplement Dates Manufacturer Received: 10/12/2022
• Supplement Dates FDA Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female