MAUDE Adverse Event Report: ARTHREX, INC.; PROSTHESIS, SHOULDER, CEMENTED

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 02/23/2024

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 (b)(6)2024, a patient-reported via phone that he was experiencing cupping in his right and left shoulder.Three years ago in south africa, he had both shoulders replaced with an unknown arthrex product, "glenoid." implanted.Four months ago, he was experiencing pain in the right shoulder, and now the left shoulder, and he can no longer do pull-ups like he used to.The surgeon mentioned to the patient that due to the glenoid not being in place over the "metal ball," he was experiencing cupping.The patient inquired about what cupping is and how it can be fixed.Additional information was received on (b)(6) 2024: additional information was received with x-rays via email on (b)(6) 2024: the patient is concerned about in vivo corrosion causing inflammation and pain.The patient experienced a lot of pain starting about four months ago.Both surgeries were done in (b)(6), sa, in late 2019 at the (b)(6).

• Brand Name: UNK
• Type of Device: PROSTHESIS, SHOULDER, 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: jared engle ; 8009337001
• MDR Report Key: 18915396
• MDR Text Key: 337799847
• Report Number: 1220246-2024-01508
• Device Sequence Number: 1
• Product Code: KWS
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/15/2024

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: 02/23/2024
• Initial Date FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other