MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVS STEM SZ 9,REV.,CTD; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number UNIVERS REVS STEM SZ 9,REV.,CTD

Device Problems Break (1069); Material Separation (1562); Component Missing (2306); Material Twisted/Bent (2981)

Patient Problem Pain (1994)

Event Date 10/27/2020

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 during a (b)(6) 2020 revision reverse total shoulder arthroplasty procedure the following issues occurred with two arthrex instruments: instrument 1: the medium t-15 driver (ar-9545-t15-02 #8001928) has been compromised.When trying to extract the central screw from a universal glenoid, the tip of the driver became twisted and a small piece broke off into the head of the central screw.There was a 5 minute delay in surgery as the screw head could no longer be accessed.The surgeon used osteotomes around the periphery of the baseplate to eventually extract the baseplate and central screw as one piece.The instrument broke into two pieces.Both pieces were recovered, but the smaller piece was lodged into the central screw implant which was not available for return.There was no unplanned incision.A second surgery is not necessary.Device will be returning for evaluation.The event did not occur during the initial use of the device.Instrument 2: the trinity baseplate impactor (ar-9165cdg #(10)051917) has been compromised.The surgeon engaged the already implanted baseplate with the impactor so that impaction might disrupt the bony bond with the baseplate.After impaction, it was noticed the blue plastic portion of the impactor had become bent and a small plastic piece had broken off.There was no delay in surgery as the surgeon had used the instrument as desired.The instrument broke into two pieces.Both pieces were recovered intra-operatively, but the small plastic piece was lost during cleaning post-surgery.There was no unplanned incision.A second surgery is not necessary.Device will be returning evaluation.The event did not occur during the initial use of the device.Additional information obtained 11/2/20: the patient's original surgery had taken place (b)(6) 2013.The patient was experiencing pain and an infection was suspected.The patient underwent the (b)(6) 2020 second surgery and all of the original arthrex implants were explanted.The case was completed by implanting an exactech interspace spacer.Hospital policy prevents release of the devices to return to the manufacturer for evaluation.The following are the original surgery implants that were explanted (b)(6) 2020: ar-7219 lot 05380, ar-9120-01 lot 2501239905, ar-9145-30 lot 2501238403, ar-9145-36 lot 2501239003, ar-9165-20 lot 2501239403, ar-9501-09rcpc lot 2501237205, ar-9502-42lcpc lot 2501246403, ar-9503l-03c lot 2501244502, ar-9504l-04 lot2501212201, ar-9550-12 lot 2501214601.

• Brand Name: UNIVERS REVS STEM SZ 9,REV.,CTD
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 10884316
• MDR Text Key: 219152804
• Report Number: 1220246-2020-02359
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888867061040
• UDI-Public: 00888867061040
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130129
• 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: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: UNIVERS REVS STEM SZ 9,REV.,CTD
• Device Catalogue Number: AR-9501-09RCPC
• Device Lot Number: 2501237205
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/03/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other