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

Model Number	N/A
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: 402283 cobalt g-hv bone cement 40g 466050 ; 1294-05-712 depuy tibial insert 182293; 1294-01-070 depuy primary femoral 3139933; 1294-33-140 depuy tibial tay 8187551; 1294-09-670 depuy lcs patella 3549523.Product location is unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03894.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Medical records identified the following: mechanical failure, loose tibial component, right tka, severe pain and instability of the knee, knee tends to collapse into varus, x-ray showed loosening of the tibial component with failure of cement mantle.Tibial component grossly loose, no adherence between the bone cement and the tibial component, bone cement mantle was quite tenuous and the cement being cracked and fissured throughout.Scar tissue excised, malposition of tibial implant (competitor device)noted.Bone cement excised, competitor implants placed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the patient underwent right total knee arthroplasty.Subsequently the patient underwent a revision procedure approximately two (2) years post implantation due to loosening of the bone cement.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: COBALT G-HV BONE CEMENT 40G
• Common Device Name: BONE CEMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11684620
• Report Number: 0001825034-2021-01116
• Device Sequence Number: 19604170
• Product Code: LOD
• UDI-Device Identifier: 00880304560796
• UDI-Public: (01)00880304560796(17)170531(10)466050
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K051532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 402283
• Device Lot Number: 466050
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention