MAUDE Adverse Event Report: RSS GLENOID BASEPLATE-S; ORTHOPEDIC SHOULDER

Catalog Number GBP-0961-094-S

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem Implant Pain (4561)

Event Date 08/30/2021

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that on (b)(6) 2021, a (b)(6) female patient with rss glenoid baseplate-s (gbp-0961-094-s) had three (3) 4.5 screws broke, and the baseplate was loose.The primary reverse total shoulder arthroplasty (rtsa) surgery took place on (b)(6) 2020.According to the surgeon, the patient was doing great then started complaining of pain thus x-ray was taken.The baseplate, screws, and glenosphere were explanted on (b)(6) 2021.In addition, the surgeon removed all broken fragments and x-ray was taken to assure that no parts left in the patient.

Manufacturer Narrative

The glenoid baseplate was not returned for evaluation therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

• Brand Name: RSS GLENOID BASEPLATE-S
• Type of Device: ORTHOPEDIC SHOULDER
• MDR Report Key: 12523976
• MDR Text Key: 273769103
• Report Number: 1651501-2021-00044
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• PMA/PMN Number: K181999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: GBP-0961-094-S
• Device Lot Number: QJ1179
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/30/2021
• Initial Date FDA Received: 09/23/2021
• Supplement Dates Manufacturer Received: 10/08/2021
• Supplement Dates FDA Received: 10/27/2021
• Date Device Manufactured: 05/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 74 YR