MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED (PS) NARROW RIGHT SIZE 6; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Swelling/ Edema (4577)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was revised approximately nine weeks post implantation due to due to pain, swelling, and possible loosening of the tibial component.During revision, no gross loosening was found in the tibial or femoral components.Mild synovitis was noted.The patella was left intact, all other components were revised without complication.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 3007963827-2022-00134.Medical product tibia cemented 5 degree stemmed right size d, item# 42532006702, lot# 64686661.Articular surface fixed bearing (ps) right 11 mm height, item# 42521400511, lot# 63750891.All poly patella cemented 29 mm diameter, item# 42540000029, lot# 64740327.Biomet bc r 1x40 us, item# 110035368, lot# f2701z129ba.Biomet bc r 1x40 us, item# 110035368.Lot# f2701z129ba.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Primary operative notes do not suggest intraoperative complications.Revision operatives notes state that revision was performed due to pain and questionable tibial loosening.Mild synovitis was noted.Neither tibial nor femoral components were grossly loose.Patella left intact, all other components revised without complication.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot 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.H6: component code: proposed component (annex g) code is mechanical g4- femur.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: FEMUR CEMENTED (PS) NARROW RIGHT SIZE 6
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14454045
• Report Number: 3007963827-2022-00133
• Device Sequence Number: 15037984
• Product Code: JWH
• UDI-Device Identifier: 00889024228740
• UDI-Public: (01)00889024228740(17)290831(10)64472820
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• 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): 08/04/2022

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: 42500006002
• Device Lot Number: 64472820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Patient Sex: Female
• Patient Weight: 84 KG