MAUDE Adverse Event Report: ENCORE MEDICAL L.P. COBALT CEMENT

Catalog Number 402433

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/23/2019

Event Type  Injury  

Event Description

Revision surgery - due to loosening of the femoral and tibial tray which involves cobalt cement.

Manufacturer Narrative

The reason for this revision surgery was reported as loosening.The previous surgery and the surgery detailed in this event occurred 12.7 years apart.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at hospital and not made available to djo surgical for examination.Because of the acquisition by djo surgical, an extended search of zimmer biomet records cannot be conducted.Any records before the acquisition date, that have not been forwarded, will not be made available.Customer complaint history of the reported device showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to loosening.The findings did not lead to a firm conclusion since the items and the needed records were not made available at the time of this investigation.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event.There are multiple factors that may contribute to an event that are outside the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: COBALT CEMENT
• Type of Device: COBALT CEMENT
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445 TX 78758 5445
• MDR Report Key: 9234934
• MDR Text Key: 163759667
• Report Number: 1644408-2019-01104
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/20/2019

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
• Device Catalogue Number: 402433
• Device Lot Number: 539710
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/24/2019
• Supplement Dates Manufacturer Received: 10/31/2019
• Supplement Dates FDA Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention