MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK COMPREHENSIVE STEM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED

Catalog Number UNK COMPREHENSIVE STEM

Device Problem Failure to Advance (2524)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

It was reported a journal article was retrieved from clinics in orthopedic surgery (2022) that reported a retrospective study from turkey.The purpose of the study was to demonstrate the clinical outcomes of two-stage implantation in reverse shoulder arthroplasty (rsa) using an antibiotic spacer in the first stage.The study reported one patient experienced an intraoperative humeral fracture during a second stage shoulder arthroplasty.No reoperation was required, and no further complications were reported.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Foreign source: event occurred in turkey.Literature - clinical outcomes of two-stage implantation in reverse shoulder arthroplasty for postinfectious end-stage glenohumeral arthritis in native shoulders: a single-center cohort study with a minimum 2-year follow-up.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6: proposed annex g code: mechanical (g04) - stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

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

• Brand Name: UNK COMPREHENSIVE STEM
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED
• 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: 15454724
• MDR Text Key: 300224409
• Report Number: 0001825034-2022-02170
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK COMPREHENSIVE STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2022
• 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
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Female