MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK BASEPLATE; PROSTHESIS, EXTREMITIES

Catalog Number UNK BASEPLATE

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown glenosphere, unknown humeral bearing, unknown humeral tray, unknown humeral stem, unknown taper adaptor.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01327.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is remains implanted the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It has been reported patient underwent initial reverse shoulder arthroplasty.Subsequently patient was revised three (3) months post implantation due to disassociation of the glenosphere from base plate.Glenosphere and poly were revised.Attempts were made and no additional information is available.

Event Description

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

Manufacturer Narrative

Concomitant medical products: unk glenosphere, unk poly.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Unable to perform a compatibility check.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot 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.

• Brand Name: UNK BASEPLATE
• Type of Device: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9924404
• MDR Text Key: 190012320
• Report Number: 0001825034-2020-01328
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK BASEPLATE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR