MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS HUMERAL STEM, 5MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number UNIVERS REVERS HUMERAL STEM, 5MM

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Pain (1994); Swelling (2091)

Event Date 01/16/2020

Event Type  Injury  

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.

Event Description

It was reported that a revision reverse total shoulder took place on (b)(6) 2020.The rep reported the revision procedure was due to a high suspicion of an infection, and the baseplate loosening.Prior to the revision procedure the patient was experiencing pain and swelling around the surgical site.X-rays were taken during a follow-up visit and revealed the loosened baseplate.Cultures were taken during the revision procedure and sent for testing.At this time an infection has not been confirmed.The primary and revision procedure were performed by the same surgeon and took place at the same facility.The rep reported at this time the date of the primary surgery, and full list of arthrex product implanted during the primary procedure is currently unknown.Additional information has been requested.The following arthrex parts were explanted during the revision procedure: ar-9503-3633-3 / lot: 18.00158 / qty.: 1, ar-9501-05p / lot: unknown / qty.: 1, ar-9555-06 / lot: 18.01505 / qty.: 1, ar-9502f-36cpc / lot: 18.00745 / qty.: 1, ar-9564-2433-lat / lot: 17.04762 / qty.: 1, ar-9563-16 / lot: 18.00182 / qty.: 1.An arthrex baseplate and screw were also removed.However, the part and lot numbers are currently unknown.

• Brand Name: UNIVERS REVERS HUMERAL STEM, 5MM
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 9659084
• MDR Text Key: 190298313
• Report Number: 1220246-2020-01637
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00888867247628
• UDI-Public: 00888867247628
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNIVERS REVERS HUMERAL STEM, 5MM
• Device Catalogue Number: AR-9501-05P
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other