MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CR 40MM GLENOSPHERE +3MM COCR; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 10/23/2020

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 location is unknown.Concomitant medical products: item number: 110031422, item name: humeral bearing, lot number: 64361197.Item number: 110031400, item name: mini humeral tray, lot number: 64691513.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 04042.0001825034 - 2020 - 04043.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent a left shoulder revision surgery approximately two months post-implantation due to dislocation.During surgery it was discovered that the poly insert was free floating, and no longer attached to the tray.The tray and liner components were removed and replaced.Attempts have been made and no additional information is available at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, d1, d2, d4, g4, g5 corrected: a2.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

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

Event Description

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

Manufacturer Narrative

(b)(4).Reported event was confirmed per the x-rays and visual assessment which stated disassociated humeral poly from humeral tray found.The returned tray and bearing showed damage.The glenosphere was not returned.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: revision was 2-month status post left total reverse shoulder noted 'did well till suffered an injury and dislocated prosthesis.' disassociated humeral poly from humeral tray found.Replaced tray and poly found stable and good rom.No complications.Device history record was reviewed and no discrepancies relevant to the reported event were found.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: CR 40MM GLENOSPHERE +3MM COCR
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10817963
• MDR Text Key: 215578678
• Report Number: 0001822565-2020-03786
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• PMA/PMN Number: K181611
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110030777
• Device Lot Number: 64416224
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PLEASE SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR