MAUDE Adverse Event Report: ARTHROSURFACE REVOMOTION REVERSE TOTAL; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 3RG9-6500

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

The case is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.

Event Description

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report does not reflect a conclusion by anika or its employees that the report constitutes an admission that the device, anika, or its employees caused or contributed to a potential patient event documented on this report.On (b)(6) 2024 it was reported to anika that during a reverse tsa procedure on a male patient of unknown age and demographic the glenosphere insertion shaft broke off and was left inside the glenoid head.The procedure continued with a15-minute delay in the procedure.There was no report of any defect with the instrument or packaging prior to the procedure.There was no negative patient impact reported.The current status of the patient is unknown.Additional information was requested.This is one of two submissions for the same event.

Event Description

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report does not reflect a conclusion by anika or its employees that the report constitutes an admission that the device, anika, or its employees caused or contributed to a potential patient event documented on this report.On 06march2024 it was reported to anika that during a reverse tsa procedure on a male patient of unknown age and demographic the glenosphere insertion shaft broke off and was left inside the glenoid head.The procedure continued with a ~15-minute delay in the procedure.There was no report of any defect with the instrument or packaging prior to the procedure.There was no negative patient impact reported.The current status of the patient is unknown.Additional information was requested.This is one of two submissions for the same event.

Manufacturer Narrative

The case is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.The reported event is not confirmed.It was reported that the glenosphere insertion shaft broke off at the attachment site.There was no negative patient impact reported.There was no reported delay in the procedure.The current status of the patient is unknown.The device was not returned to the manufacturing plant for analysis.Retention inventory is not maintained for this product.A review of the device history record was performed.There was no nonconformances documented in manufacturing record.The device was manufactured to applicable procedures and specifications.A three-year retrospective review of nonconformances for this product was performed.There was no nonconformances that was related to the reported event.A supplemental report will be submitted upon receipt of new and relevant information.The reported event will continue to be monitored and trended for future analysis.

• Brand Name: REVOMOTION REVERSE TOTAL
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHROSURFACE; 28 forge parkway; franklin MA 02038
• Manufacturer (Section G): PRIMO MEDICAL GROUP; 75 mill street; stoughton MA 02072
• Manufacturer Contact: keith kelly ; 28 forge parkway; franklin, MA 02038
• MDR Report Key: 18980997
• MDR Text Key: 338992970
• Report Number: 3004154314-2024-00002
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3RG9-6500
• Device Lot Number: 75KB2891
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1