MAUDE Adverse Event Report: ARTHREX, INC. UNIVERSAL GLENOID - BASEPLATE SMALL; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number UNIVERSAL GLENOID - BASEPLATE SMALL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Skin Discoloration (2074); Toxicity (2333)

Event Date 06/08/2015

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was requested but 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 due to a metallosis the shoulder and the arm of the patient turned black.The surgery which led to the reported event was a shoulder prosthesis which was performed on the (b)(6) 2015.According to the customer arthrex devices were implanted during the initial surgery in 2015.Currently it is not known in which hospital the initial surgery took place.Therefore no further information about the detailed incident and the used arthrex part numbers are currently available.Update 12-oct-2020: initially the lot numbers which were affected were not provided however further information were now provided that the following parts were used during the initial surgery 2015: ar-9120-01, lot: 140113110.Ar-9145-30, lot: 140123108.Ar-9504s-04, lot: 2501212801.Ar 9165-15, lot: 140103207.Ar-9145-30, lot: 2501417704.Ar-9502-36cpc, lot: 140120310.Ar -9501-07cpc, lot: 2501215303.Ar-9503s-03, lot: 140104307.Ar-9555-15, lot:2501215101.Ar-7213, lot: 12812.Ar-7200, lot: 12795.However it could not be confirmed which device has led to the reported issue and if the devices are available for evaluation.

• Brand Name: UNIVERSAL GLENOID - BASEPLATE SMALL
• 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: 10746372
• MDR Text Key: 213477435
• Report Number: 1220246-2020-02261
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867057340
• UDI-Public: 00888867057340
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K142863
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/28/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: UNIVERSAL GLENOID - BASEPLATE SMALL
• Device Catalogue Number: AR-9120-01
• Device Lot Number: 140113110
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other