MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS APEX HUMERAL STEM, 6MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	UNIVERS APEX HUMERAL STEM, 6MM
Health Effect - Clinical Codes	Loss of Range of Motion (2032); No Code Available (3191)
Date of Event	10/16/2020
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 through the surgical outcome system that a patient may have had an issue as a result of surgery involving arthrex implants.Upon further investigation it was discovered that a patient had a (b)(6) 2018 total shoulder arthroplasty procedure.On (b)(6) 2018, a few days post surgery, the patient was experiencing inability to extend fingers.The patient was diagnosed with radial nerve palsy.Patient was able to extend wrist on (b)(6) 2019 but had difficulty typing.An emg was recommended.Patient was told nerve palsy would resolve within the year.The patient consulted with an orthopedic hand surgery specialist who suggested a tendon transfer for the nerve palsy.It is unknown if the patient has proceeded with a second surgery with another surgeon.The patient has had no further surgeries with the original surgeon.The following are the arthrex products that were implanted (b)(6) 2018: ar-9100-06s / lot: 10233337.Ar-9106-01 / lot: 1027261806.Ar-9142-17p / lot: 170097421.

• Brand Name: UNIVERS APEX HUMERAL STEM, 6MM
• 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: 10694532
• Report Number: 1220246-2020-02233
• Device Sequence Number: 3058375
• Product Code: KWS
• UDI-Device Identifier: 00888867134416
• UDI-Public: 00888867134416
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K131633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/17/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: UNIVERS APEX HUMERAL STEM, 6MM
• Device Catalogue Number: AR-9100-06S
• Device Lot Number: 10233337
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 10/17/2020
• 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