MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS HUMERAL STEM, SIZE 8; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number	UNIVERS REVERS HUMERAL STEM, SIZE 8
Health Effect - Clinical Code	Fall (1848)
Date of Event	04/09/2020
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 disposition is unknown and it 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 during a revision reverse shoulder to a closed reduction procedure on (b)(6) 2020, the surgeon was checking if the peripheral screws of the 24mm +2 mgs baseplate were loose.When the surgeon tightened the screws, the blue handle of the ar-1999hh, ratcheting handle was clicking and did not have a positive stop.The surgeon determined that the mgs baseplate was loose, so they proceeded to explant the screws and baseplate without any issues.The mgs baseplate was implanted prior to the revision surgery.The implants were converted to tornier.At the time of initial report to arthrex no further details were available.Additional information obtained 4/13/2020 and 4/15/2020: the initial report provided was not a complete description and further, more detailed, information has been obtained to clarify the entire patient related events.The female patient underwent a primary reverse total shoulder procedure on (b)(6) 2019.It was reported that the patient had suffered a fall (date unknown) which resulted in a periprosthetic humeral fracture.The patient underwent a first revision on (b)(6) 2020 where the surgeon explanted the following devices and replaced them with another manufacturer¿s products: ar-9501-08p, univers humeral stem size 8, lot 19.00151, ar-9502f-36cpc, univers revers suture cup, 36 (neutral), lot 18.01499, ar-9503s-06, humeral insert s/36 +6 to fit in 36 cup, lot 160044609.It was reported that due to the patient¿s non-compliance she later experienced a reverse shoulder dislocation.The patient then underwent a 2nd closed reduction revision procedure on 4/9/20.When accessing the baseplate, it was determined to be loose and therefore removed.During the revision the remaining 10/8/19 primary surgery devices were explanted and another manufacturer¿s products were then implanted.The following is the list of the products explanted: ar-9560-24-2, 24mm +2 lat baseplate, modular, lot 5674, ar-9564-2436-lat, 36 +4 lat/24 glenosphere, lot 18.00692, ar-9563-28, 5.5 x 28mm peripheral locking screw, lot 2019001687, ar-9563-32, 5.5 x 32mm peripheral locking screw, lot 18.00166, ar-9561-20s, 20mm central screw, modular, lot 6473, ar-7219, fiberwire suture from suture kit, lot 19893.The two revision surgeries were performed by the same surgeon at the same facility, but the primary surgery was performed at a different facility by a different surgeon.

• Brand Name: UNIVERS REVERS HUMERAL STEM, SIZE 8
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10028430
• Report Number: 1220246-2020-01830
• Device Sequence Number: 14283128
• Product Code: HSD
• UDI-Device Identifier: 00888867250406
• UDI-Public: 00888867250406
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K161782
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2020

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: 06/30/2024
• Device Model Number: UNIVERS REVERS HUMERAL STEM, SIZE 8
• Device Catalogue Number: AR-9501-08P
• Device Lot Number: 19.00151
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 05/06/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR