MAUDE Adverse Event Report: ARTHREX, INC.; TOT ANAT SHOULDR PROSTH, UNCEM

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 02/27/2024

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.

Event Description

On 2/29/2024, a clindex notification was received indicating that a severe complication occurred that resulted in medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function.Patient arrived to clinic for standard of care post-op 1 visit where x-ray imaging revealed a posteriorly dislocated anatomic arthroplasty.Patient was pain-free and compliant with protocol and did not know at what point it dislocated.Patient went in for a revision surgery on (b)(6) 2024.Shoulder was able to be reduced, but shoulder still wanted to sublux with motion.Surgical exploration revealed an intact subscapularis and uncomplicated prosthesis.Due to persistent instability, the decision to convert to a reverse arthroplasty was made.Patient was doing well following surgery and will continue to follow up with clinic per standard of care.The original procedure was performed on (b)(6) 2024, no further information was reported.

• Brand Name: UNK
• Type of Device: TOT ANAT SHOULDR PROSTH, UNCEM
• 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: jared engle ; 8009337001
• MDR Report Key: 18896543
• MDR Text Key: 337580257
• Report Number: 1220246-2024-01445
• Device Sequence Number: 1
• Product Code: QHQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/13/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other