MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN GLENOID; PROSTHESIS, EXTREMITY

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problem Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is "a" on-going event concerning the patient inflammation.Significant dates regarding date of implant and explant are as follows: primary "implatation"- unknown revision to reverse- (b)(6) 2018.Revision to spacer- (b)(6) 2018.Patient has not yet been implanted with permanent devices.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was not reviewed as the necessary product/lot code combination was not provided.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.Not returned to manufacturer.

Event Description

Patient was primarily implanted many years ago (date unknown) with a hemi shoulder.The patient was converted to a reverse shoulder due to inflammation on (b)(6) 2018.The patient reported another surgeon had previously stated he had a nickel allergy; but did not want dr.(b)(6) to test him for it.An augmented glenoid was implanted and the stem was retained.The patient returned a few weeks later with on-going inflammation.The patient was tested for inflammatory markers and the tests were returned negative.On (b)(6) 2018 the surgeon chose to err on the side of caution and remove the reverse shoulder implants.As an on-going measure due to the inflammation, the patient was implanted with a spacer while now awaiting pmi to provide titanium implants.No further information available at this time.

• Brand Name: UNKNOWN GLENOID
• Type of Device: PROSTHESIS, EXTREMITY
• 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: 8107544
• MDR Text Key: 128464688
• Report Number: 0001825034-2018-10182
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2018
• 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: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention