MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS APEX HUMERAL STEM, 8MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	UNIVERS APEX HUMERAL STEM, 8MM
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/17/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that during a tsa conversion to an rtsa, upon trying to remove the tsa univers apex stem, the slap hammer nubbin broke off in the extraction tool leaving us with a broken slap hammer.This resulted in a difficult time trying to remove the stem adding at least 30 minutes to the case.No additional incisions were made.Surgeon used same deltoid/pectoral approach for total shoulder arthroplasty procedure.They were unable to perform a normal removal technique so they used a tps burr to help facilitate the removal of the apex stem.No additional anesthesia was needed.Product ar-9202-14, lot 250150205, will be returned for evaluation.The original tsa procedure took place (b)(6) 2020 during which the following devices had been implanted: ar-9106-02, univers vaultlock glenoid, lot 1027261917.Ar-9100-08s, univers apex humeral stem, lot 10321781.Ar-9150-19p, usp ii humeral head, lot 10291252.The original tsa and rtsa were preformed by the same surgeon at the same facility.Conversion procedure was being performed due to a failed rotator cuff.All original implants were explanted during the procedure.

• Brand Name: UNIVERS APEX HUMERAL STEM, 8MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10279202
• Report Number: 1220246-2020-01945
• Device Sequence Number: 689914
• Product Code: KWS
• UDI-Device Identifier: 00888867134508
• UDI-Public: 00888867134508
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K131633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/15/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: UNIVERS APEX HUMERAL STEM, 8MM
• Device Catalogue Number: AR-9100-08S
• Device Lot Number: 10321781
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other