MAUDE Adverse Event Report: ZIMMER ORTHO TRABECULAR METAL REVERSE SHOULDER SYSTEM; ZIMMER ORTHO INSERT HUMERUS REVERSE

Model Number 00-4349-040-06

Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Date 05/09/2016

Event Type  malfunction  

Event Description

Male patient had shoulder arthroplasty reverse (left) in (b)(6), implant due to primary osteoarthritis (not trauma) due to rotator cuff tear; patient completed all post-op rehab.Several months later, patient presented to ortho office four days out of dislocation event; revision of (l) reverse prosthesis.He had had no injury, no episode, not over-working shoulder and woke up with increased pain in shoulder.Patient had insert humerus reverse tm 7d 40x+6mm explanted during that visit.Manufacturer response for zimmer ortho insert humerus reverse, (brand not provided) (per site reporter): mfg representative indicates: this is an item that would ideally need to be investigated by zimmer biomet as i have submitted a product experience report regarding this implant.

• Brand Name: TRABECULAR METAL REVERSE SHOULDER SYSTEM
• Type of Device: ZIMMER ORTHO INSERT HUMERUS REVERSE
• Manufacturer (Section D): ZIMMER ORTHO; 345 east main street; warsaw, IN 46580
• MDR Report Key: 5750767
• MDR Text Key: 48225891
• Report Number: 5750767
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 00-4349-040-06
• Device Catalogue Number: 62749515
• Other Device ID Number: 7D 40X+6MM
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/20/2016
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 87