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

Catalog Number 402282

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377)

Event Date 09/05/2019

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 - initial left total knee arthroplasty performed.Subsequently, the patient was revised due to pain, limited motion, osteolysis, and aseptic loosening.The patella was left intact.All other components were revised without complication.

Manufacturer Narrative

Corrected data: see b.3., d.6b.& g.1.Manufacuturer narrative: the reason for this revision surgery was reported as pain, limited motion, osteolysis and aseptic loosening.The previous surgery and the surgery detailed in this event occurred 3.5 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 hospital and not made available to djo surgical for examination.The device history record was not found among djo and available zimmer biomet records.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, limited motion, osteolysis, and aseptic loosening.The findings did not lead to a firm conclusion since the needed records were not made available at the time of this investigation.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.

Manufacturer Narrative

Manufacturer narrative: the reason for this revision surgery was reported as pain, limited motion, osteolysis and aseptic loosening.The previous surgery and the surgery detailed in this event occurred 3 years and 6 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 device was disposed of at hospital and not made available to djo surgical for examination.This investigation is limited in scope as only partial information was provided to djo surgical for review.The revised item was not returned for examination and the lot number was not provided.To adequately investigate this event, lot number was necessary.Given the limited information, a search of djo and available zimmer biomet records for the previous surgery produced no results, therefore; the item could not be verified.If this information is submitted at a future date, this investigation will be re-evaluated.Customer complaint history of the reported item showed no present trends or on-going issues that are needing a review.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.

• 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: 11829529
• MDR Text Key: 250801072
• Report Number: 1644408-2021-00405
• 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,Followup
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 402282
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 402282 LOT UNKNOWN
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 62 YR