MAUDE Adverse Event Report: ENCORE MEDICAL L. P. COBALT CEMENT; COBALT HV BONE CEMENT 40G

Catalog Number 402282

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 03/22/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturer narrative: additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Event Description

Revision surgery - due to patient underwent revision surgery due to loosening of her knee components.

Manufacturer Narrative

The reason for this revision surgery was reported as loosening of knee components.The previous surgery and the surgery detailed in this event occurred 2 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 devices were disposed of at hospital and not made available to djo surgical for examination.This evaluation is limited in scope as the items associated with this investigation were not returned to djo surgical for examination.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.Customer complaint history of the reported items showed no present trends or on-going issues that are needing a review.The root cause of this complaint was reported as loosening.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.The surgeon performed this revision to remedy the patient's condition.This complaint will be closed pending receipt of additional information.No further action is deemed necessary at this time.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

Event Description

Revision surgery - due to loosening of knee components.

• Brand Name: COBALT CEMENT
• Type of Device: COBALT HV BONE CEMENT 40G
• Manufacturer (Section D): ENCORE MEDICAL L. P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 11671098
• MDR Text Key: 245569110
• Report Number: 1644408-2021-00240
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 00888912338301
• UDI-Public: (01)00888912338301
• Combination Product (y/n): N
• PMA/PMN Number: K051496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 402282
• Device Lot Number: 058600
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 402282, LOT 058600; 402282, LOT 058600
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR