MAUDE Adverse Event Report: ZIMMER, INC.; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 03/04/2020

Event Type  malfunction  

Event Description

Patient had motorcycle accident last year and suffered shoulder injury.Reverse left shoulder arthroplasty.Instability of implant identified with dislodgment of prosthesis on x-ray approximately 5 weeks later.Patient was taken back to surgery the next day for a revision.Per dr., looking back at original post-op x-rays, it appears that this dislodgment could be seen on x-ray about a month earlier.Radiology review does not indicate this.Concerns for infection of wound now, presenting to ed for assessment.Implant sent back to manufacturer zimmer bio-met.Per the orthopedic surgeon: i reached out to the rep.He sent photos into the zimmer biomet headquarters and will be sending the implants this week most likely.I do not know if/when we will have correspondence about the prosthesis from them.The prosthesis was a zimmer biomet reverse shoulder arthroplasty.Implants: 40 mm 3 lateralized glenoid sphere on versa dial coupler; standard 6 offset humeral tray with 3 retentive humeral polyethylene bearing.

• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ZIMMER, INC.; 56 east bell drive; warsaw IN 46581
• MDR Report Key: 10183718
• MDR Text Key: 196107563
• Report Number: 10183718
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/04/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23725 DA