MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUTHART RT PM MINI REVERSE GLENOID; PROSTHESIS, SHOULDER

Catalog Number PM0002193

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Information (3190)

Event Date 06/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.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.Product not returned.

Event Description

It was reported that there was an issue with the implant not assembling correctly.There was a 45 minute delay in the procedure as a result of the event.Subsequently, the patient is scheduled for a future revision procedure; however, no revision procedure has been reported to date.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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

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: patient identifier,date of report, event, initial reporter name and address, pma/510k, type of reportable event, if follow-up, what type.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 further noted that the patient has a sufficient glenoid deficiency and bone loss/erosion.

Event Description

It was reported that there was an issue with the implant not assembling correctly.There was a 45 minute delay in the procedure as a result of the event.It was noted that the patient has a sufficient glenoid deficiency and bone loss/erosion.Subsequently, the patient was revised.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified the device with some unknown staining and some minor damage.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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: HUTHART RT PM MINI REVERSE GLENOID
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8816783
• MDR Text Key: 151889896
• Report Number: 0001822565-2019-03132
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PM0002193
• Device Lot Number: 912770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention