MAUDE Adverse Event Report: ZIMMER, INC. UNK ZIMMER ROTATING HING KNEE; KNEE PROSTHESIS

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 08/13/2014

Event Type  Injury  

Event Description

It is reported that during the revision surgery, it was noted that the coupling pin had dislocated and the threading of the pin shows signs of wear.

Manufacturer Narrative

This report will be amended when our investigation is complete.

• Brand Name: UNK ZIMMER ROTATING HING KNEE
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; po box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 4147218
• MDR Text Key: 4771625
• Report Number: 1822565-2014-01291
• Device Sequence Number: 1
• Product Code: HRZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/05/2014

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/03/2014
• Initial Date FDA Received: 10/02/2014
• 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): Required Intervention