MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL TRAY FIXED BEARING SIZE 5; PROSTHESIS, KNEE

Model Number N/A

Device Problems Material Erosion (1214); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problems Failure of Implant (1924); Pain (1994); Osteolysis (2377); Ambulation Difficulties (2544); Metal Related Pathology (4530)

Event Type  Injury  

Event Description

It was reported through a journal article that a patient underwent a primary right total knee arthroplasty on an unknown date.Approximately two years later, the patient reported increasing medial knee pain without history of injury.Around 3.5 years postop, the patient presented with sudden worsening pain, varus deformity, and inability to bear weight.X-rays showed substantial medial tibial bone loss and tibial tray fracture.The patient was revised on an unknown date; during which, loosening of the tray over the tibial osteolytic defects was noted.The femoral component was stable and undamaged.The tibial tray and poly insert were revised without complications.Histologic samples showed metal debris within the surrounding soft tissues.The patient reportedly had no further complications after the revision procedure.

Manufacturer Narrative

(b)(4); report source: foreign - slovenia; literature - fokter, s.K., gubeljak, n., punzón-quijorna, e., pelicon, p., kelemen, m., vavpetic, p., predan, j., ferlic, l., & novak, i.(2022).Total knee replacement with an uncemented porous tantalum tibia component: a failure analysis.Materials (basel, switzerland), 15(7), 2575.Https://doi.Org/10.3390/ma15072575; the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-01460.

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 and reviewed by a health care professional.Review of the available records identified the following: pain, tibial bone loss, tibial tray fracture, medial part loose over a large proximal medial tibial bone defect, osteolysis, subsidence, metal debris noted in tissue sample, signs of bone ingrowth with insufficient bone-implant contact.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: TIBIAL TRAY FIXED BEARING SIZE 5
• 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: 17037918
• MDR Text Key: 316297940
• Report Number: 0001822565-2023-01459
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: SI
• PMA/PMN Number: K173057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• 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: 00595404701
• Device Lot Number: 63809608
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2017
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 88 KG