MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET CC I-BEAM TRAY 75MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Associated products : item#: 402282; cobalt hv bone cement 40g; lot#: 058600, qty 2.Item#: 184766; series a 3 peg std 34x8.5; lot#: 304200.Item#: 183128; van ps open intl fem-lt 65; lot#: j3941926.Item#: 183099; vanguard fem pegs set 2; lot#: 875950.Item#: ep-183642; e1 vngd ps tib brg 71/75x12; lot#: 871170.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it's location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-01091, 0001825034-2021-01232.
Event or Problem Description
It was reported by patients¿ legal counsel that the patient underwent a left knee revision procedure approximately two years post-implantation, due to tibial loosening.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).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 tibial component obviously loose.Explanted femoral component without substantial bone loss.Patella was not revised.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.

• Brand Name: BIOMET CC I-BEAM TRAY 75MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11725263
• Report Number: 0001825034-2021-01233
• Device Sequence Number: 19660330
• Product Code: JWH
• UDI-Device Identifier: 00880304007512
• UDI-Public: (01)00880304007512(17)270116(10)J2958309
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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 Model Number: N/A
• Device Catalogue Number: 141224
• Device Lot Number: J3958309
• 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: 04/26/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 04/27/2021
• 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