MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS APEX HUMERAL STEM, 8MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number UNIVERS APEX HUMERAL STEM, 8MM

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Discomfort (2330); Joint Laxity (4526)

Event Date 11/11/2021

Event Type  Injury  

Event Description

On 11/19/2021, it was reported by a sales representative via email that an ar-9100-08s humeral stem and ar-9154-21p humeral head were originally implanted on (b)(6) 2019.The glenoid aspect of the surgery seemed fine both during pre-op assessment as well as intra-op.About a year and a half after implantation, patient began to experience pain and discomfort, it looked as if the stem had subsided and it was loose.During the revision surgery on (b)(6)2021, samples were taken from both the joint space and canal area.All tests came back negative for infection, which leads to the issue being aseptic loosening.Once the stem was removed there was no bony on or ingrowth in the implant.Surgeon was able to replace both humeral stem and humeral head with an ar-9501-10p revers humeral stem, an ar-9501-fx10n revers fracture adapter, and an ar-9150-19p univers humeral head.

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.If the device becomes available for evaluation, a follow-up report will be submitted.

• Brand Name: UNIVERS APEX HUMERAL STEM, 8MM
• 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: 12954076
• MDR Text Key: 281907758
• Report Number: 1220246-2021-04070
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888867134508
• UDI-Public: 00888867134508
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: UNIVERS APEX HUMERAL STEM, 8MM
• Device Catalogue Number: AR-9100-08S
• Device Lot Number: 10264781
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2021
• Date Device Manufactured: 12/19/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other