MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE COBALT CHROME STANDARD HUMERAL TRAY 44MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 010000589,comprehensive mini baseplate & taper adaptor, 926840; 115310,versa-dial glenosphere standard, 626240; xl-115363,arcomxl standard humeral bearing, 073050; 113631,comprehensive humeral stem¿mini, 950590.Therapy date - (b)(6) 2016.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-09920, 0001825034-2018-09921, 0001825034-2018-09923, 0001825034-2018-09924.Patient not yet revised.

Event Description

It has been reported that patient had initial comprehensive reverse shoulder arthroplasty.Four (4) months post initial surgery, patient had abscess on incision site.Six (6) months later, irrigation and debridement was performed where abscess was opened and cleaned and cultures were taken.No additional patient consequences were reported.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.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.

• Brand Name: COMPREHENSIVE REVERSE COBALT CHROME STANDARD HUMERAL TRAY 44MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8004636
• MDR Text Key: 124979178
• Report Number: 0001825034-2018-09922
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K113069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 115370
• Device Lot Number: 597170
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 84