MAUDE Adverse Event Report: ZIMMER, INC. COBALT G-HV BONE CEMENT 40G; BONE CEMENT, ANITBIOTIC

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 12/15/2015

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, "loosening or displacement of the prosthesis.".

Event Description

Legal counsel for patient reported patient was revised approximately 5 years post-implantation due to cement loosening.This report is based on allegations set forth in plaintiff's complaint, and the allegations contained therin are unverified.Additional information received in the patient's operative reports confirm patient was revised due to cement loosening.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of operative notes.Op notes indicates prosthetic loosening of her tibial tray.She had pain and radiographic evidence of prosthetic loosening of the femoral and tibial loosening.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COBALT G-HV BONE CEMENT 40G
• Type of Device: BONE CEMENT, ANITBIOTIC
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6377114
• MDR Text Key: 69092997
• Report Number: 0001822565-2017-01489
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK051532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2015
• Device Model Number: N/A
• Device Catalogue Number: 402283
• Device Lot Number: 604410
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 99