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

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: unknown aesculap as vega tibial component unknown.Unknown aesculap unknown femoral component unknown.Unknown aesculap unknown bearing unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02402, 0001825034 2021-01211, 0001825034-2021-01213.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: revision due to painful instability.Wear noted on the medial bearing.Tibial and femoral components removed at the bone-cement interface, lack of adherence of the cement-component interface noted.Competitor patella left intact, all other components revised without complication.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 patient underwent a right knee revision procedure approximately 3 years post implantation due to pain, discomfort, instability, and difficulty ambulating caused by aseptic loosening of the tibia component.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
The initial was submitted under a wrong manufacturing site.This report should be voided, as it was submitted in error.This product was acquired by another company.Further reports will be submitted under the corrected manufacturing site.
Event or Problem Description
The initial was submitted under a wrong manufacturing site.This report should be voided, as it was submitted in error.This product was acquired by another company.Further reports will be submitted under the corrected manufacturing site.

• Brand Name: COBALT G-HV BONE CEMENT 40G
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11711900
• Report Number: 0001825034-2021-01212
• Device Sequence Number: 11823228
• Product Code: LOD
• UDI-Device Identifier: 00880304560796
• UDI-Public: (01)00880304560796(17)170930(10)526010
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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: 09/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 402283
• Device Lot Number: 526010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 06/08/2021
• 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