MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN MINI BASEPLATE; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Pain (1994)

Event Date 09/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.Concomitant medical products: item number: 118000, item name: versa-dial taper adaptor, lot number: 384660.Item number: 115310, item name: comprehensive reverse shoulder glenosphere, lot number: 164650.Item number: unknown, item name: unknown bearing, lot number: unknown.Item number: unknown, item name: unknown stem, lot number: unknown.Item number: unknown, item name: unknown tray, lot number: unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03773.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient has been indicated for shoulder revision due to disassociation.Surgery has not occurred to date.Attempts have been made and no additional information is available at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information provided by the customer.Dhr was unable to be reviewed as the lot number for the device is unknown.The root cause is 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.

• Brand Name: UNKNOWN MINI BASEPLATE
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10666844
• MDR Text Key: 211242735
• Report Number: 0001825034-2020-03774
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/12/2020
• Supplement Dates Manufacturer Received: 12/29/2020
• Supplement Dates FDA Received: 12/30/2020
• 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: 66 YR