MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NONPOROUS STEMMED TIBIAL BASEPLATE SIZE 0 RIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problems Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544); Subluxation (4525)

Event Date 03/31/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-01315.D10 medical devices: unknown femoral catalog#: ni lot#: ni.Unknown tibial insert catalog#: ni lot#: ni.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Hospital the revision occurred at: (b)(6) hospital.

Event Description

It was reported that patient under a right knee revision due to loosening and device migration.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

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

Event Description

It was reported that patient underwent a right total knee arthroplasty.The patient underwent a poly exchange approximately five years later due to disassociation of the tibial insert.Subsequently, approximately seven years later the patient presented with severe pain, instability, and subluxation due to wear and disassociation of the tibial insert.A second revision was performed and the tibial insert was found to be loose from the tibial tray and was easily removed from the joint space.The patella was well-fixed with good tracking and was left intact.All other components were revised without complication.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-01650.D10 medical devices: articular surface ultracongruent size 00 0 right 19 mm height catalog#: 00542802019 lot#: 62320698.Gender solutions female (gsf) femoral component nonporous size 1, right catalog#: 00541401402 lot#: 61789868.All poly patella size 1 8 mm thickness catalog#: 00542000801 lot#: 61773963.Palacos rg 1x40 single catalog#: 00111314001 lot#: 71294252.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records and radiographs were provided.However, radiographs were not sent to for review, as timeline provided sufficient dictation of findings.Medical records were reviewed by a health care professional.Review of the available records identified: instability with subluxation, wear, and locking mechanism failed, patient presents severe pain, poly insert was disassociated, patella was not revised.A definitive root cause cannot 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 Description

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

• Brand Name: NONPOROUS STEMMED TIBIAL BASEPLATE SIZE 0 RIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16941068
• MDR Text Key: 315320545
• Report Number: 0001822565-2023-01316
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070214
• 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,Followup,Followup
• Report Date: 09/22/2023

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 Expiration Date: 03/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 630701200
• Device Lot Number: 61749741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/16/2023
• Supplement Dates Manufacturer Received: 05/15/2023; 05/26/2023; 09/22/2023
• Supplement Dates FDA Received: 06/13/2023; 06/20/2023; 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2011
• 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; SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 104 KG