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

Model Number	GLENOID, POLY WITH KEEL, MEDIUM
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Tissue Damage (2104); Foreign Body In Patient (2687)
Date of Event	11/16/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported via the arthrex ethics helpline that the following issue has occurred: patient had left shoulder replacement surgery approximately 9 years ago.X-rays have been taken on (b)(6) 2020 and patient was referred back to his original surgeon.It has been discovered that a piece of the arthrex prosthesis has broken off and is moving about in the shoulder girdle area, under the skin.The surgeon has plans to perform a second surgery (b)(6) 2020, it was indicated in the initial report that the issue could possibly be due to a fall and that the issue may have occurred approximately (b)(6) 2020.Patient stated that he is currently experiencing no pain and his joint is functioning as it always has.Additional information obtained 1/4/2020: the patient's original surgery took place (b)(6) 2012.The following are the arthrex products that were implanted during the original surgery: ar-9104-02 glenoid, poly with keel, medium.Ar-9150-19p usp ii humeral head 50/19.Ar-9100-10p univers ii humeral stem.Patient's relative reports that the patient experienced, in his left shoulder, a disproportionate amount of pain and motion restrictions that occurred mid may 2020.He had assisted a tv technician to move a flat screen tv off the wall and plate it on a foot stool 2 feel away.The evening patient had radiating pain down his lue and the next day he was taken to the er.It was diagnosed as soft tissue injury.They were able to relieve the pain with acupuncture sessions and then added celebrex to his daily meds.After that episode he had not had pain or restriction in that shoulder.It is reported that the glenoid piece came loose (100% of it).It was under the skin and on top of the muscle.Patient underwent surgery (b)(6) 2020 to remove the loose implant.Additional information obtained 1/8/2021: patient relative states the facility did not give her the explanted glenoid due to biohazard contamination.Facility provided patient with two pictures of the explanted glenoid which patient relative has provided to arthrex.Relative states patient is having no issues with the joint so feels best to leave it alone.

• Brand Name: GLENOID, POLY WITH KEEL, MEDIUM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11228581
• Report Number: 1220246-2021-02486
• Device Sequence Number: 4104349
• Product Code: KWS
• UDI-Device Identifier: 00888867057296
• UDI-Public: 00888867057296
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K010124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/26/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: GLENOID, POLY WITH KEEL, MEDIUM
• Device Catalogue Number: AR-9104-02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 01/26/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other