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

Catalog Number 402283

Device Problems Loose or Intermittent Connection (1371); Unstable (1667)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091)

Event Date 10/08/2018

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

Reported incident - due to patient with history of 3 previous left knee revisions for pain, instability and loosening, with last one performed on (b)(6) 2018 with implantation of oss system.Left knee aspiration performed due to pain and swelling, results positive.Surgeon planned for ii stage revision, with explant of oss system and placement of antibiotic spacer along with treatment of iv antibiotics for 6 weeks.Positive intra operative knee cultures - gemella morbillforum.Stage ii performed with explant of antibiotic spacer and implantation of oss system.

Manufacturer Narrative

Manufacturer narrative: the reason for this reported event was pain and swelling.The previous surgery and the surgery detailed in this event occurred 5 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 the hospital and not made available to djo surgical for examination.A review of the implant device history record (dhr) shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material report (ncmr) associated with the product that may have contributed to the reported event.The device 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 pain and swelling.There were no findings during this evaluation that indicate 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 or inhibited the patient's immune system.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 if it becomes available.

• Brand Name: COBALT BONE CEMENT
• Type of Device: COBALT G-HV BONE CEMENT 40G
• Manufacturer (Section D): ENCORE MEDICAL L. P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 10766190
• MDR Text Key: 214070933
• Report Number: 1644408-2020-01054
• Device Sequence Number: 1
• Product Code: LOD
• 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: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Catalogue Number: 402283
• Device Lot Number: 428670
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 94