MAUDE Adverse Event Report: DJO / ENCORE MEDICAL, L. P. DJO SHOULDER REPLACEMENT BASEPLATE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number 508-32-204

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Failure of Implant (1924)

Event Date 12/01/2021

Event Type  Injury  

Event Description

Bilateral premature baseplate failure of reverse shoulder prosthesis.Same manufacturer and implant for bilateral baseplate failure.Fda safety report id# (b)(4).

• Brand Name: DJO SHOULDER REPLACEMENT BASEPLATE
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): DJO / ENCORE MEDICAL, L. P.
• MDR Report Key: 12961240
• MDR Text Key: 282040573
• Report Number: MW5105924
• 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: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2021

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 508-32-204
• Device Lot Number: 769P1852, 769P1778
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White