MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS II HUMERAL STEM 6MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	UNIVERS II HUMERAL STEM 6MM
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/16/2019
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 while extracting a tsa long stem, after using the flexible osteotomes, the slap hammer, ar-9202-14, was put on to the stem.After numerous hits, the ball broke off.There were no fragments in the patient.The rep opened a second set and used the slap hammer from that tray to complete the case with no adverse effect to the patient.Additional information obtained 10/31/2019: the case was a revision procedure, moving to a reverse total shoulder.The previous implant had been in for several years.Flexible osteotomes were used extensively.It was a long stem and a number of tries, back and forth from slap hammer to osteotomes was performed when the ball of the slap hammer popped off.Additional information obtained 11/1/2019: the original arthrex univers procedure took place in 2009.Specific procedure date is unknown.The original 2009 procedure took place at the same facility as the current (b)(6) 2019 revision procedure.The original part numbers that were implanted during the 2009 procedure are currently unknown.The (b)(6) 2019 procedure was reported to be a standard revision for a failed rotator cuff.It was that the patient had not suffered any injury or trauma prior to the revision surgery.The following arthrex univers revers products were implanted during the revision procedure: ar-9564-2436-lat (lot 19.00012).Ar-9503s-03 (lot 19.00215).Ar-9501-06p (lot 18.01549).Ar-9502f-36cpc (lot 18.01791).Ar-9555-06 (lot 19.00048).Ar-9560-24-4 (lot 5675).Ar-9561-20s (lot 5648).Ar-9563-28 (lot 2019000055) qty 2.Ar-9507s (lot 10259907).Additional information obtained 12/9/2019: the patient¿s original surgery was performed on (b)(6) 2012, not 2009 as originally reported.The following are the original implant device part numbers that were explanted during the (b)(6) 2019 revision procedure to a reverse total shoulder: ar-9148-21p.Lot# 0929011.Ar-9105-01.Lot#1202006.Ar-9100-06p.Lot#2501125211.

• Brand Name: UNIVERS II HUMERAL STEM 6MM
• 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: 9519381
• Report Number: 1220246-2019-01529
• Device Sequence Number: 374472
• Product Code: KWS
• UDI-Device Identifier: 00888867057050
• UDI-Public: 00888867057050
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K071032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/26/2019

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 Model Number: UNIVERS II HUMERAL STEM 6MM
• Device Catalogue Number: AR-9100-06P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 12/26/2019
• 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