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

Device Problem Naturally Worn (2988)

Patient Problems Pain (1994); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implant date: (b)(6) 2019.Explant date:(b)(6) 2019.Concomitant medical products: unk poly.Unk tray.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02291, 0001825034-2020-02293.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.

Event Description

It was reported that patient underwent a shoulder arthroplasty approximately eleven (11) months ago.Approximately one (1) month post-implantation, patient was revised due to pain and discomfort.During the revision surgery, it was discovered that the poly had dissociated from the humeral tray and the glenosphere was severely scratched.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; g4; g7; h1; h2.Upon receiving additional information of the reported event, it was determined to be not reportable as scratching and damage to the glenosphere likely occurred secondary to the poly disassociating form the tray resulting in the glenosphere rubbing directly on the tray.The initial report should be voided.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 GLENOSPHERE
• Type of Device: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10134741
• MDR Text Key: 194613048
• Report Number: 0001825034-2020-02292
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10.
• Patient Outcome(s): Hospitalization; Required Intervention