MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE D; PROSTHESIS, KNEE

Model Number N/A

Device Problems Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Pain (1994); Synovitis (2094); Swelling/ Edema (4577)

Event Date 03/01/2022

Event Type  Injury  

Event 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.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 3007963827-2022-00133.Concomitant medical products: medical product: femur cemented (ps) narrow right size 6 item# 42500006002, lot# 64472820.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.

Manufacturer Narrative

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.

Event Description

No further event information available at the time of this report.

• Brand Name: TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE D
• Type of Device: 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: 14453703
• MDR Text Key: 292599132
• Report Number: 3007963827-2022-00134
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024471047
• UDI-Public: (01)00889024471047(17)300531(10)64686661
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42532006702
• Device Lot Number: 64686661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/17/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 08/01/2022
• Supplement Dates FDA Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 84 KG