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

Catalog Number	402282
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Joint Laxity (4526)
Date of Event	10/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical devices: item #141221 - biomet cc i-beam tray 63mm - part #j3871554; item #183022 - vanguard cr ilok fem-lt 57.5 -part# 722670; item #183420- vngd cr tib brg 10x63/67- part #748220; item #184784 - series a pat thn 31 3 peg - part #987190.
Event or Problem Description
It was reported patient underwent a revision procedure approximately 18 months post implantation due to pain, tibial loosening, instability, and loss of function.Intraoperatively, it was found that the cement had de-bonded from the tibial component.The initial zb patella was retained, remaining devices were removed, and competitor product was placed.Attempts to obtain additional information have been made; however, no more is available at this time.
Event or Problem Description
Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: COBALT HV BONE CEMENT 40G
• Common Device Name: BONE CEMENET
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11701968
• Report Number: 0001825034-2021-01189
• Device Sequence Number: 3659918
• Product Code: LOD
• UDI-Device Identifier: 00880304560789
• UDI-Public: (01)00880304560789(17)171130(10)058600
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K051496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2021

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: 11/30/2017
• Device Catalogue Number: 402282
• Device Lot Number: 058600
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 05/11/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention