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

Model Number	UNIVERS II HUMERAL STEM 9MM
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	09/17/2019
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 not returned for evaluation.At this time the device remains in the patient.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 by the patient that he had arthrex implants implanted in 2018.According to the implant card, the following devices were implanted: ar-9100-09p & ar-9148-21p.The patient was continuously experiencing very intense (unbearable) pain.The patient was treated several times by different doctors due to the pain.The results showed that the prosthesis position is too high and has only a small joint gap.Due to the constant friction, the patient now has a chronic infection.The second opinion of the doctors was that the removal of the entire shaft (not cemented) is necessary.However, this leads to the fact that the entire humerus must be completely damaged.

• Brand Name: UNIVERS II 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: 9155772
• Report Number: 1220246-2019-01341
• Device Sequence Number: 2157327
• Product Code: KWS
• UDI-Device Identifier: 00888867057104
• UDI-Public: 00888867057104
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2019

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: UNIVERS II HUMERAL STEM 9MM
• Device Catalogue Number: AR-9100-09P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 10/04/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other