MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 10MM MICRO; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number 113610

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

Patient Problem Bone Fracture(s) (1870)

Event Date 11/29/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).-customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Zimmer biomet will continue to monitor for trends.Associated products and reports: 0001822565-2022-03533, item# 00-4326-040-46; lot# 62700439.0001825034-2022-02748-1, item# 113032; lot# 214780.0001825034-2022-02747-1, item# 118001; lot# 139970.

Event Description

It was reported a patient had a left total shoulder revision six (6) years post implantation due to a large, non-contained, glenoid defect.During the removal of the humeral component, the patient developed a greater tuberosity fracture.Initially it was a small non-displaced fracture, but as the implant was well fixed and unable to be removed, an episiotomy was performed.This led to a displaced fracture.An open reduction internal fixation (orif) was performed, and the fracture was stabilized.No further complications were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; g3; g6; h1; h2; h3; h6 proposed g code: mechanical (g04) - stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: 'because i knew she could not have single stage, i decided to remove the humeral component even though it was well fixed'- used moreland chisels and then tried to tap out humeral component but did not tap out.A small, non-displaced crack in the greater tuberosity, which eventually became a displaced crack.Episiotomy performed and implant came out easily; open reduction and internal fixation of greater tuberosity fracture.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.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: COMP PRIMARY STEM 10MM MICRO
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• 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: 16272586
• MDR Text Key: 308482401
• Report Number: 0001825034-2023-00191
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 113610
• Device Lot Number: 115800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female