MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NATURAL TIBIA TM TWO-PEG POROUS FIXED BEARING LEFT SIZE F; PROSTHESIS, KNEE

Model Number	42-5300-075-01
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	09/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Implant date occurred between (b)(6) 2019-(b)(6) 2019.Medical product: articular surface mc left 10 mm height: catalog#42512100810, lot#64237120; femur trabecular metal cr narrow porous: catalog#42502206601, lot#63685612; nexgen complete knee solution, tm standard primary patella: catalog#00587806532, lot#64097505.A visual inspection of the item could not be performed as no product was returned nor were pictures provided.Dhr was reviewed and no discrepancies related to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: limited obliquity of the femoral and tibial component on the ap film; no radiolucency along the patellar component; no fracture; possible narrowing of the lateral component could indicate underlying polyethylene wear; no definite evidence for loosening; normal sizing.Root cause was unable to be determined.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 patient underwent left knee revision approximately three years post implantation due to reported pain in tibia and suspected loosening of the tibia.Tibial component and articular surface were exchanged without complication.Attempts were made and no further information was provided.

• Brand Name: NATURAL TIBIA TM TWO-PEG POROUS FIXED BEARING LEFT SIZE F
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12561206
• Report Number: 0001822565-2021-02846
• Device Sequence Number: 19182996
• Product Code: MBH
• UDI-Device Identifier: 00889024510579
• UDI-Public: (01)00889024510579(17)280930(10)64055813
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K173417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2021

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 Model Number: 42-5300-075-01
• Device Catalogue Number: 42530007501
• Device Lot Number: 64055813
• 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: 09/17/2021
• Initial Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention