MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS HUMERAL STEM, SIZE 7; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number UNIVERS REVERS HUMERAL STEM, SIZE 7

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 07/27/2020

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 a patient had undergone an shoulder procedure (b)(6) 2019.Due to upper arm/ biceps tendon pain and discomfort the original surgeon performed a revision rtsa procedure (b)(6) 2020 at the same facility.During the revision procedure while attempting to remove the cup screw from the original procedure the driver tip twisted and the screw stripped.Sales rep states nothing out of the ordinary was noticed/ mentioned by the surgeon during the procedure.The revision was completed without any complications.The following devices were explanted during the revision and exchanged for larger sizes: ar-9564-2436-lat (lot 18.01992), ar-9501-07p (lot 18.02015), ar-9502f-36rcpc (lot 170111405), ar-9503s-06 (lot 19.00773), ar-9502rsc (lot 18.01082).The explanted devices are not available to return for evaluation.

• Brand Name: UNIVERS REVERS HUMERAL STEM, SIZE 7
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: 10414362
• MDR Text Key: 203164189
• Report Number: 1220246-2020-02040
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00888867250390
• UDI-Public: 00888867250390
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161782
• 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: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: UNIVERS REVERS HUMERAL STEM, SIZE 7
• Device Catalogue Number: AR-9501-07P
• Device Lot Number: 18.02015
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/02/2019
• 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