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

Catalog Number 402283

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 11/15/2018

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery was due to patient began experiencing severe and persistent pain.The previous surgery and the surgery detailed in this event occurred 2.75 years apart.Customer complaint history of the reported item showed no present trends or on-going issues that are needing a review.This investigation is limited in scope as only partial information was provided to djo surgical - (b)(4) for review.The revised item was not returned for examination and the item and lot number was not provided.To adequately investigate this event, the part or lot number are necessary.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.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

Event Description

Reported incident - due to patient began experiencing severe and persistent pain, discomfort, instability, and difficulty ambulating caused by mechanical loosening of the defective cobalt g-hv bone cement.

• 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
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5448
• Manufacturer Contact: teffany hutto ; 9800 metric blvd.; austin, TX 78758-5445
• MDR Report Key: 11330304
• MDR Text Key: 231943431
• Report Number: 1644408-2021-00142
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 00888912338318
• UDI-Public: (01)00888912338318
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051532
• 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: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 402283
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention