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

Catalog Number 402283

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Discomfort (2330); Ambulation Difficulties (2544)

Event Date 02/13/2019

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 - patient began experiencing severe and persistent pain, discomfort, instability and difficulty ambulating caused by aseptic loosening of the defective as vega knee and cobalt ghv bone cement.

Manufacturer Narrative

The reason for the incident was due to pain, discomfort, instability and difficulty ambulating caused by aseptic loosening.The previous surgery and the surgery detailed in this event occurred 2 years and 8 months 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.A search of djo and available zimmer biomet records for the device history records produced no results, therefore, the items could not be linked to a specific device history record and the actual date of manufacture cannot be determined with confidence.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 pain, discomfort, instability and difficulty ambulating caused by aseptic loosening.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.

• Brand Name: COBALT CEMENT
• Type of Device: COBALT G-HV BONE CEMENT 40G
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx
• MDR Report Key: 10200839
• MDR Text Key: 196765083
• Report Number: 1644408-2020-00483
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 00888912338318
• UDI-Public: (01)00888912338318
• Combination Product (y/n): N
• PMA/PMN Number: K051532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

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: 07/31/2017
• Device Catalogue Number: 402283
• Device Lot Number: 865260
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 08/13/2020
• Supplement Dates FDA Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 402283 LOT 526010
• Patient Outcome(s): Other
• Patient Age: 57 YR