MAUDE Adverse Event Report: ZIMMER CONTINUUM 56; PROTHESIS HIP

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); No Code Available (3191)

Event Date 12/19/2013

Event Type  Injury  

Event Description

Total hip replacement using a zimmer continuum 56.Possible deteriorating of implant and infections.Will require complete removal and replacement of right hip implant.

• Brand Name: CONTINUUM 56
• Type of Device: PROTHESIS HIP
• Manufacturer (Section D): ZIMMER
• MDR Report Key: 7063863
• MDR Text Key: 93190204
• Report Number: MW5073591
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 11/24/2017

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 79