MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN NEXGEN LPS-FLEX TM PATELLA; PROSTHESIS, KNEE

Model Number N/A

Device Problems Fracture (1260); Failure to Osseointegrate (1863)

Patient Problems Failure of Implant (1924); Inadequate Osseointegration (2646)

Event Type  Injury  

Event Description

A journal article was retrieved from therapeutics and clinical risk management (2021) that reported a retrospective study from japan.The purpose of the study was to evaluate the short- to mid-term clinical results of posterior-stabilized trabecular metal total knee arthroplasty (tka) with cementless fixation of all components and investigate the radiographic changes of tibial and patellar components and cut bone surfaces over time.The study reviewed 128 knees from 88 consecutive patients who had undergone initial tka with nexgen lps-flex tm implants from april 2011 to march 2016.The number of patients included in final study and completed follow ups were 66 knees in 45 patients.The study reported two patellar components fractured at the base of the peg and required revision.Both injuries were caused by repeated falls within 12 months after surgery.In the pathological examination of the fractured patellar components, fibrous connective tissue and bone ingrowth was found in the porous regions of the pegs, whereas the baseplate region demonstrated insufficient early bone ingrowth after 12 months of surgery.

Manufacturer Narrative

(b)(4).Report source: foreign: (b)(6).Report source: literature - momose, t., nakamura, y., nakano, m., maeda, t., morioka, s., sobajima, a., nakatsuchi, y., takahashi, j., & nawata, m.(2021).Short- to mid-term clinical outcomes of posterior-stabilized cementless total knee arthroplasty with trabecular metal components. therapeutics and clinical risk management, 17, 809¿816.Https://doi.Org/10.2147/tcrm.S320941.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.

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.

Event Description

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

• Brand Name: UNKNOWN NEXGEN LPS-FLEX TM PATELLA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14452548
• MDR Text Key: 292223080
• Report Number: 0001822565-2022-01512
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• 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: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• 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: 08/29/2022
• 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