MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR HUMERAL STEM 12 MM STEM DIAMETER 130 MM STEM LENGTH; PROSTHESIS, EXTREMITIES

Catalog Number 00430001213

Device Problem Unstable (1667)

Patient Problem Joint Dislocation (2374)

Event Date 08/03/2021

Event Type  Injury  

Event Description

It was reported approximately three (3) months ago that the clinical study patient underwent a planned procedure to locate and tenotomize the subscapularis tendon.Patient was experiencing instability and the stem and humeral head were removed.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00234.Concomitant medical products: item# 00430204015; lot# 62803239.Item# 00432604000; lot# 62729443.Full establishment name - (b)(6).Foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.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.

Event Description

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

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: has a previous history of shoulder dislocations.Since the study has also dislocated her shoulder (b)(6) 2017 and again on (b)(6) 2017.This ae was not caused by a traumatic event.The patient underwent revision of the head and stem due to posterior instability on (b)(6) 2021.At 5-year follow up, atraumatic shoulder dislocation (b)(6) 2020.Patient has a previous history of atraumatic shoulder dislocations.Ongoing.Op report showed failed right shoulder arthroplasty, posteriorly unstable.Head and stem removed easily, cultures taken.Glenoid well-fixed and left in place, new stem and head placed.No intraop complications.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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.

• Brand Name: MODULAR HUMERAL STEM 12 MM STEM DIAMETER 130 MM STEM LENGTH
• Type of Device: PROSTHESIS, EXTREMITIES
• 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: 12821229
• MDR Text Key: 280829963
• Report Number: 0001822565-2021-03310
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K982981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00430001213
• Device Lot Number: 62982676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2015
• 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
• Treatment: SEE NARRATIVE IN H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female