MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GLENOID COMPONENT PEGGED 52 MM DIAMETER ARTICULAR SURFACE; PROSTHESIS, SHOULDER

Catalog Number 00430008700

Device Problems Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Osteopenia/ Osteoporosis (2651)

Event Date 10/08/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: modular humeral head 27 mm head height 52 mm spherical head diameter cat#: 00430005227, lot#: ni.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported a patient underwent a right total shoulder arthroplasty.Subsequently, patient underwent a revision approximately seventeen years later due to pain and an aseptically loose glenoid component.During revision, it was found that the pegs had fractured off the glenoid component.Glenoid and humeral head were replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: primary op notes identified no complications.Revision op notes were reviewed and identified patient reports worsened pain (4/10), incision healing well, no sign of infection.Steroid injection provided in right shoulder.The glenoid was clearly loose.The pegs of the glenoid were broken.The glenoid and head removed, new head placed, glenoid defects filled with bone grafting, stem left intact.X rays were not sent to further review as the medical notes confirmed the event.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause could not 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: GLENOID COMPONENT PEGGED 52 MM DIAMETER ARTICULAR SURFACE
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11012182
• MDR Text Key: 221548799
• Report Number: 0001822565-2020-03982
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K103404
• 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: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00430008700
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 134