MAUDE Adverse Event Report: ENCORE MEDICAL L.P BONE CEMENT; COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT

Catalog Number 402439

Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery was reported as dislocation, loosening and migration.The actual length of in-vivo for the items listed is unknown as the original surgery date was not provided or could be established.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.A review of the device history records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event.The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the previous surgery.Customer complaint history of the reported devices 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 dislocation, loosening, and migration.There were no findings during this evaluation that indicate that the reported devices were 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 of the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.

Event Description

Reported incident: the products of djo were associated products in a complaint regarding dislocation, loosening, and migration.

• Brand Name: BONE CEMENT
• Type of Device: COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer Contact: teffany hutto ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 9854015
• MDR Text Key: 189885693
• Report Number: 1644409-2020-00199
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 00888912338387
• UDI-Public: (01)00888912338387
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092150
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/19/2020

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: 07/31/2012
• Device Catalogue Number: 402439
• Device Lot Number: 632240
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 03/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2010
• 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): Other