MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PT HYBRID GLEN POST REGENEREX; PROSTHESIS, SHOULDER

Catalog Number	PT-113950
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Synovitis (2094)
Date of Event	08/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a revision procedure approximately 20 months post implantation after a sudden onset of pain and pop in the shoulder.During the revision, the surgeon excised scar tissue, synovitis, and adverse tissue reaction.The glenoid was floating free in the joint and fractured through the metal stem within the glenoid vault.The glenoid post, glenoid, adapter, and head were revised.The stem was retained.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: sm hybrid glenoid base 4 mm, cat# 113952, lot# 952230.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001825034 - 2022 - 02020.
Additional Manufacturer Narrative
Visual examination of the provided photograph identified that the regenerex post is fractured.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional and a timeline was created.Review of the available records identified the following: general plus regional block; pain and a pop in her shoulder, imaging was concerning for dissociation of the glenoid component; significant amount of scar tissue from the previous surgery encountered; no rotator cuff tear present; no loosening of the stem, retained; synovitis and altr excised; ¿the glenoid component was found free in the joint having failed and fractured through the metal stem within the glenoid vault.¿ 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
No further event information is available at the time of this report.

• Brand Name: PT HYBRID GLEN POST REGENEREX
• Common Device Name: PROSTHESIS, SHOULDER
• 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: 15335836
• Report Number: 0001825034-2022-02019
• Device Sequence Number: 17752109
• Product Code: KWS
• UDI-Device Identifier: 00880304459854
• UDI-Public: (01)00880304459854(17)290515(10)482100
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K060694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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,Followup
• Report Date (Section B): 11/16/2022

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 Catalogue Number: PT-113950
• Device Lot Number: 482100
• 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: 08/15/2022
• Supplement Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2019
• 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: Required Intervention; Hospitalization
• Patient Sex: Female