MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL STEM 9MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	HUMERAL STEM 9MM
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/08/2019
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 requested/is expected but has 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 that the patient underwent a shoulder "arthoplasty" procedure where a 9mm humeral stem, ar-9100-09 was implanted.After an unknown amount of time, the patient began having persistent pain.A revision surgery was performed on (b)(6) 2019 and the stem, ar-9100-09 was removed.There were two additional implants that were explanted, the stem and the head; however at this time, the part numbers are unknown.The "trunion" from the stem was stuck inside the head and unable to be separated so the rep was not able to read the item number on the head component.The revision was completed with hardware from another manufacturer.
Additional Manufacturer Narrative
Complaint was confirmed.Visual evaluation revealed chipping at the end of the inclination block from screw extraction.The metal was noted to be extremely thin and worn down over time.The underside of the trunnion displayed deep circular grooves in the metal, indicating that it had been loose and rotating against the inclination block while in the joint space.Material had been worn away so significantly that the grit blasting was gone and a circular dish has been created on the underside of the trunnion.Minor superficial scratches were noted along the outer diameter of the stem.Damage to the stems inclination block and trunnion is evident of loose components, where over time material was worn away as the trunnion rotated on the inclination block.It should be noted that the universe i system was obsoleted in 2005 and the revision surgery to explant the devices occurred in.

• Brand Name: HUMERAL STEM 9MM
• 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: 8290228
• Report Number: 1220246-2019-00876
• Device Sequence Number: 1991209
• Product Code: KWS
• UDI-Device Identifier: 00888867134522
• UDI-Public: 00888867134522
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K010124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2019

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
• Operator of Device: Health Professional
• Device Model Number: HUMERAL STEM 9MM
• Device Catalogue Number: AR-9100-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 03/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR