MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PT HYBRID GLEN POST REGENEREX; EXTEMITY - IMPLANT

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

It was reported that the comprehensive modular hybrid glenoid post - regenerex broke off the modular hybrid glenoid base.The patient got a comprehensive tsa shoulder implanted approximately 3 years ago.At 1-year control, the surgeon found via an x-ray the regenerex post was broken off the glenoid base.Furthermore, in the x-ray taken last month, the position of the post appears to have changed further.For now, doctors plan to monitor the progress, but reoperation may be a possibility in the future.Attempts have been made and there is no further information at this time.

Manufacturer Narrative

(b)(4).G2: japan.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : remains implanted.

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: b1 - product problem (e.G., defects/malfunctions) was inadvertently not clicked in original submission.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: initial anatomic alignment and normal appearance of the right shoulder arthroplasty with subsequent post fracture.A definitive root cause cannot be determined.The reported event is confirmed as an x-ray was provided.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.

• Brand Name: PT HYBRID GLEN POST REGENEREX
• Type of Device: EXTEMITY - IMPLANT
• 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: 18371688
• MDR Text Key: 331090711
• Report Number: 0001825034-2023-03045
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00880304459854
• UDI-Public: (01)00880304459854(17)290822(10)444370
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K060694
• 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: 02/22/2024

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 Model Number: N/A
• Device Catalogue Number: PT-113950
• Device Lot Number: 444370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female