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

Model Number N/A

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

Patient Problems Pain (1994); Reaction (2414); Ambulation Difficulties (2544)

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.Products were implanted sometime in (b)(6) 2020.Concomitant medical products: item number: unknown, item name: unknown stem, lot number: unknown.Item number: unknown, item name: unknown head, lot number: unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 03777.0001822565 - 2020 - 03779.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 ongoing pain and difficulty ambulating post-revision.Patient is also experiencing complications due to an allergic reaction of nickel and titanium.Attempts have been made and no additional information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Part and lot identification are necessary for review of device history records, neither were provided.No product was returned; visual and dimensional evaluations could not be performed.Complaint history review cannot be performed without product identification.Insufficient information provided.Unable to perform a compatibility check.Medical records were not provided.A definitive root cause could not be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.

Event Description

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

• Brand Name: UNKNOWN GLENOID COMPONENT
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10817366
• MDR Text Key: 215541078
• Report Number: 0001822565-2020-03778
• Device Sequence Number: 1
• Product Code: KWS
• 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: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 12/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other