MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN NEXGEN ARTICULAR SURFACE; PROSTHESIS, KNEE

Model Number N/A

Device Problem Degraded (1153)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

A journal article was retrieved from the knee (2024) that reported a study from the united kingdom that used total knee arthroplasty (tka) explant analysis to trend polyethylene (pe) wear patterns between posterior-stabilized (ps) and cruciate-retaining (cr) designs.The study reviewed 73 explanted nexgen fixed-bearing tkas (42 cr and 31 ps) used in combination with the option stemmed tibial tray.(cement information not provided in the article).Patients were divided into two cohorts of aseptic loosening as reason for revision and all other reasons.Of the ps group, there were 15 males, 16 females, with a mean age of 68 years at the time of revision (range, 51-81 years), and a median duration in vivo of 5.0 years (range, 4.1-6.0 years).Of the cr group, there were 18 males, 24 females, with a mean age of 66 years at the time of revision (range, 40-84 years), and a median duration in vivo of 4.3 years (range, 1.6-6.0 years).The study reported 23 patients in the ps group were revised due to aseptic loosening of the tibia.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).G2: foreign - united kingdom.G2: citation - bhalekar, r.M., wells, s.R., matthew nargol, m., shariatpanahi, s., nargol, a.V.F., waller, s., wildberg, l., tilley, s., & langton, d.J.(2024).Aseptic loosening of the option stemmed tibial tray in the zimmer nexgen lps total knee arthroplasty system. the knee, 47, 1¿12.Advance online publication.Https://doi.Org/10.1016/j.Knee.2023.12.004.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: 0001822565-2024-00179.

Event Description

Articular surface wear was also noted.

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 unable to be performed as the lot number of the device involved in the event is unknown.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.

• Brand Name: UNKNOWN NEXGEN ARTICULAR SURFACE
• 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: 18533426
• MDR Text Key: 333089990
• Report Number: 0001822565-2024-00180
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 23
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Hospitalization