MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS SUTURE CUP, 36 (NEUTRAL); K161782

Model Number UNIVERS REVERS SUTURE CUP, 36 (NEUTRAL)

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Inflammation (1932)

Event Date 05/13/2021

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

The patient had a reverse shoulder done on (b)(6) 2019.She was having inflammation problems at the site; there was another case done on (b)(6) 2021 to remove the devices.They checked for infection; tests were negative.The surgeon determined that the stem and cup were loose; they were removed from the patient.A size 8 stem and cup were inserted into the patient for a total shoulder repair.

Manufacturer Narrative

Complaint not confirmed, the cup was undamaged and was found to seat on the returned stem as intended.No abnormality was observed that may have contributed to the event.

• Brand Name: UNIVERS REVERS SUTURE CUP, 36 (NEUTRAL)
• Type of Device: K161782
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11947591
• MDR Text Key: 254801197
• Report Number: 1220246-2021-03224
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00888867234192
• UDI-Public: 00888867234192
• Combination Product (y/n): N
• PMA/PMN Number: K161782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNIVERS REVERS SUTURE CUP, 36 (NEUTRAL)
• Device Catalogue Number: AR-9502F-36CPC
• Device Lot Number: 19.02582
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/07/2021
• Supplement Dates Manufacturer Received: 05/17/2021
• Supplement Dates FDA Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other