MAUDE Adverse Event Report: ZIMMER, INC. NEXGEN LPS-FLEX ARTICULAR SURFACE; KNEE PROSTHESIS

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Fall (1848)

Event Date 11/02/2016

Event Type  Injury  

Event Description

It has been reported that the patient underwent a total knee arthroplasty revision due to dislocation of the articular surface following a fall.

Manufacturer Narrative

Concomitant medical products: stem extension replacement screw, catalog # 00598009000, lot# 62778689; femoral component precoat for cemented use only size f left, catalog # 00599001601, lot# 63058138; tibial component stemmed precoat use of this tibial component with legacy knee - constrained condylar knee (lcck) articulating surfaces requires using, catalog # 00598003702, lot# 62899123; taper stem plug, catalog # 00596009900, lot# 62808326.The reported event was unable to be confirmed as not product was returned; visual and dimensional evaluations could not be performed.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required as no trends were identified.Before this incident, patient hasn¿t experienced any pain.So, we can conclude that root cause is related to patient fall.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.

Manufacturer Narrative

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

• Brand Name: NEXGEN LPS-FLEX ARTICULAR SURFACE
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6136403
• MDR Text Key: 61158518
• Report Number: 0001822565-2016-04462
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK042271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00596203214
• Device Lot Number: 62320985
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2013
• 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