MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN HYBRID GLENOID; PROSTHESIS, SHOULDER

Model Number N/A

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

Patient Problems Adhesion(s) (1695); Scar Tissue (2060)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: unknown humeral stem cat#ni lot#ni.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Sperling, john w, marigi, erick m, lenartowicz, karina a, jennewine, brenton, throckmorton, thomas w.(2022) clinical and radiographic outcomes of hybrid glenoid fixation with a central porous titanium post: analysis of 713 consecutive shoulders, journal of shoulder and elbow surgery.Https:// doi.Org/10.1016/j.Jse.2021.12.033.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 00618.

Event Description

It was reported in a journal article from the journal of shoulder and elbow surgery, which studied patient outcomes after primary elective hybrid total shoulder arthroplasties, that patient underwent reoperation or revision due to arthrofibrosis.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were corrected/updated: b4, b5, g3, g6, h2, h6, h10 upon further review, the root cause of the reported event was determined to be unrelated to the implanted zimmer biomet arthrofibrosis is a condition of the knees that may cause pain, stiffness, and limited range of motion.This is due to scar tissue and/or contractures that develop within the knee joint after surgery or an untreated injury.Treatment may include physical therapy, manipulation under anesthesia or arthroscopy in which the scar tissue is removed.

• Brand Name: UNKNOWN HYBRID GLENOID
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13825111
• MDR Text Key: 287521837
• Report Number: 0001825034-2022-00617
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 H10
• Patient Outcome(s): Required Intervention; Hospitalization