MAUDE Adverse Event Report: ARTHREX, INC. GLENOID, POLY WITH KEEL, SMALL; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number GLENOID, POLY WITH KEEL, SMALL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Toxicity (2333)

Event Date 03/13/2009

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 by the patient that she underwent total joint replacement in her shoulders in 2009 and 2010.Patient is currently under care for systemic sclerosis and has bloodwork done every 6 months.The cobalt/chromium level in her blood is increasing.At time of initial report part numbers were not provided but have been requested.Additional information obtained 11/17/20: the patient underwent right shoulder surgery (b)(6) 2009.Patient also had left shoulder surgery (b)(6) 2010 approximately one year later the patient had a revision surgery on the left shoulder both the (b)(6) 2010 surgery and the revision of that surgery were done by the same surgeon/facility as the 2009 procedure.Patient is unsure what the revision surgery actually entailed.Patient is seeing a rheumatologist for her systemic sclerosis and it has been discovered that she has cob alt in her blood.Patient was referred to her prior hip replacement surgeon (different than shoulder surgeon).Mri's wee performed and showed no compromise.Patient believes this was performed approximately (b)(6) 2019.At this time they do not believe that any of her current health issue are due to the cobalt issue.The concern is that the cobalt issue has increased.The patient has requested and has been provided the full material composition of the known arthrex devices which were implanted (b)(6) 2009.The known arthrex products are as follows: ar-9104-01 (lot 08.048) glenoid, ar-9100-08p (lot 0831002) univers humeral stem, ar-9144-17p (lot 0830007) usp ii humeral head.

• Brand Name: GLENOID, POLY WITH KEEL, SMALL
• 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: 10962154
• MDR Text Key: 220137997
• Report Number: 1220246-2020-02394
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888867057289
• UDI-Public: 00888867057289
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GLENOID, POLY WITH KEEL, SMALL
• Device Catalogue Number: AR-9104-01
• Device Lot Number: 08.048
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2020
• 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