MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVS CUP,42/NEUTRAL CTD; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number UNIVERS REVS CUP,42/NEUTRAL CTD

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/29/2018

Event Type  Injury  

Manufacturer Narrative

Complaint confirmed.Visual evaluation revealed both the screw and the raised side of the screw hole on the cup had fractured.The fragments were not received for evaluation.The opposite side of the fractured hole was also damaged.In addition, there were scratches and tool marks on both inner and outer surfaces plus a visible wear pattern was observed.The device met all material specifications as received.A root cause for the event cannot be determined at this time.

Event Description

It was reported that the patient required a revision surgery.Original date of surgery was (b)(6) 2015.Per the rep, the ar-9502-42cpc broke in half in the patient when he was opening a bottle of water.The revision was (b)(6) 2018.Parts removed were ar-9502-42cpc (lot 12.714), ar-9550-12 (lot 13.490) and a ¿liner¿ (no part # found per the rep).These were replaced with ar-9502f-42cpc and ar-9550-15.The original cup was done at the 135 degree slot; the revision was done at the 155 degree slot.Original surgery was done in (b)(6), revision in (b)(6) (different surgeons).Additional information obtained 9/13/18: the sales rep has confirmed that, per the surgeon's decision, the distal part of a screw, which is part of the universal reverse cup (ar-9502-42cpc), was stuck in the 135 degree hole of the universal reverse stem that was not explanted.

• Brand Name: UNIVERS REVS CUP,42/NEUTRAL CTD
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 7884924
• MDR Text Key: 120538303
• Report Number: 1220246-2018-00645
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867061187
• UDI-Public: 00888867061187
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142863
• 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: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNIVERS REVS CUP,42/NEUTRAL CTD
• Device Catalogue Number: AR-9502-42CPC
• Device Lot Number: 12.714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Date Manufacturer Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other