MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS GLENO 36 +4 LAT; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	UNIVERS REVERS GLENO 36 +4 LAT
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/22/2019
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 needed to have a revision surgery on a reverse total shoulder case.The original case was (b)(6) 2019; the revision was (b)(6) 2019.The cases were at different facilities with the same doctor.Patient is a (b)(6) man; at the 2-week follow up, he reported hearing a ¿noise¿ at the site.Post-op compliance in unknown.An x-ray showed that the glenosphere had disassociated from the baseplate and the inferior screw had backed out.Removed from the patient was ar-9502f-36lcpc (170134308), ar-9504s-04 (18.00715), ar-9503s-03c (170062310), ar-9145-36 (18.00587).Ar-9501-09c (18.00233), ar-9503s-03c (170062310).Remaining in the patient from the original surgery was ar-9120-01, ar-9165-30nl, ar-9145-24.Inserted into the patient at the revision was ar-9145-36, ar-9504s-04, ar-9501-09p, ar-9502f-36lcpc, ar-9555-06, ar-9555-09.
Additional Manufacturer Narrative
Complaint confirmed.X-rays after the initial surgery and prior to the revision surgery were provided.The x-ray from after the initial surgery appears to show the glenosphere in place but no determination can be made as to peripheral screw positioning.The x-ray taken prior to the revision surgery reveals the inferior locking screw associated with the baseplate to be protruding above the top surface of the baseplate and the glenosphere disassociated.Neither the baseplate nor its locking screws were returned for evaluation.As neither the baseplate nor its locking screws were returned for evaluation, the failure mode could not be replicated.No fretting of the male taper of the glenosphere was observed.Material and dimensional analysis confirmed the glenosphere met all as-received specifications.It was noted that patient post-op compliance was unknown.

• Brand Name: UNIVERS REVERS GLENO 36 +4 LAT
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8344187
• Report Number: 1220246-2019-00895
• Device Sequence Number: 14030358
• Product Code: PHX
• UDI-Device Identifier: 00888867061408
• UDI-Public: 00888867061408
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 03/14/2019

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 Expiration Date: 07/31/2023
• Device Model Number: UNIVERS REVERS GLENO 36 +4 LAT
• Device Catalogue Number: AR-9504S-04
• Device Lot Number: 18.00715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 03/14/2019
• 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