MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET CC I-BEAM TRAY 67MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377)
Date of Event	09/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Associated products : item#: 402282; cobalt hv bone cement 40g; lot#: unknown, qty.2; item#: 183024 vanguard cr ilok fem-lt 60 lot#: 714060; item#: 189048  vngd ant stblzd brg 18x67 lot#: 862450.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: 0001825034-2021-01239, 0001825034-2021-01236.
Event or Problem Description
It was reported that the initial left total knee arthroplasty performed five years ago.Subsequently, the patient was revised approximately 3.5 years later due to pain, limited motion, osteolysis, and aseptic tibial loosening.The patella was left intact.All other components were revised without complication.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records noting patient presented with pain, aseptic loosening, limited mobility and osteolysis.Tibial component easily removed and there was no bone cement around the keel down into the tibia itself.There was some fibrous tissue with no ingrowth from a cemented knee stem.Patella was left intact and all other components replaced with competitor product.Dhr was reviewed and no discrepancies were found.The root cause is 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: BIOMET CC I-BEAM TRAY 67MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11724051
• Report Number: 0001825034-2021-01240
• Device Sequence Number: 11590387
• Product Code: JWH
• UDI-Device Identifier: 00880304000766
• UDI-Public: (01)00880304000766(17)251109(10)J3682882
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K915132
• 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: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2021

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: 11/09/2025
• Device Model Number: N/A
• Device Catalogue Number: 141222
• Device Lot Number: J3682882
• 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: 04/29/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 04/30/2021
• 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