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

Catalog Number PT-113950

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Synovitis (2094)

Event Date 08/10/2022

Event Type  Injury  

Event 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.

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.

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 Description

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

• Brand Name: PT HYBRID GLEN POST REGENEREX
• Type of Device: 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
• MDR Text Key: 299062842
• Report Number: 0001825034-2022-02019
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00880304459854
• UDI-Public: (01)00880304459854(17)290515(10)482100
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 09/01/2022
• Supplement Dates Manufacturer Received: 11/14/2022
• Supplement Dates FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2019
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female