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

Catalog Number 402282

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 08/12/2014

Event Type  Injury  

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

Reported incident - initial right total knee arthroplasty performed.Subsequently, a legal notice was received for unknown allegations.

Manufacturer Narrative

Manufacturer narrative: the reason for this revision surgery was unknown.The actual length of in-vivo for the item listed is unknown.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.A review of the device history record (dhr) shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There was no non-conforming material report (ncmr) associated with the product that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery.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 unknown reason.There were no findings during this evaluation that indicate the reported device was defective.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.Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

• Brand Name: BONE 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: 11829530
• MDR Text Key: 250804671
• Report Number: 1644408-2021-00406
• Device Sequence Number: 1
• Product Code: LOD
• 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: 06/17/2021

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 Expiration Date: 01/31/2016
• Device Catalogue Number: 402282
• Device Lot Number: 859820
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2021
• Initial Date FDA Received: 05/14/2021
• Supplement Dates Manufacturer Received: 05/28/2021
• Supplement Dates FDA Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 62 YR