MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE MODULAR HYBRID GLENOID BASE; PROSTHESIS, SHOULDER

Model Number N/A

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

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 07/31/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 115736, comprehensive nano humeral component pps, 945850; 118001, comprehensive standard taper adaptor, 975080; 113042, versa-dial humeral head, 238100; pt-113950, modular hybrid glenoid post¿regenerex, 279250.(b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 08938; 0001825034 - 2018 - 08939; 0001825034 - 2018 - 08941.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.Patient not yet revised.

Event Description

It was reported that patient had initial comprehensive anatomic nano arthroplasty.Subsequently, patient began experiencing severe pain and limited range of motion two (2) years post initial surgery.An open biceps tenotomy and open ac joint excision were performed to treat the pain.Outcome of treatment is pending.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).X-rays and medical history of the patient were reviewed and the reported event was not confirmed.X-ray review has no findings and there are no intraoperative complications as per operative notes.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.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.

• Brand Name: COMPREHENSIVE MODULAR HYBRID GLENOID BASE
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7876331
• MDR Text Key: 120249566
• Report Number: 0001825034-2018-08940
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K060694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 113954
• Device Lot Number: 494700
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR