MAUDE Adverse Event Report: ZIMMER, INC. FEM.NG LPS FLEX PRL OPT.M.G DX; PROSTHESIS, KNEE

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Scratched Material (3020)

Patient Problem No Information (3190)

Event Date 01/05/2017

Event Type  malfunction  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.Concomitant products: nexgen tibial tray catalog 00598004702 lot 60831373.Unknown lps flex 10mm tibial articular surface.This report is number 2 of 3 mdrs filed for the same event (reference 1822565-2017-00805 / 1822565-2017-00805).

Event Description

Patient underwent a right knee revision procedure approximately nine years post implantation due to the articular surface loosening.

Manufacturer Narrative

Concomitant medical products: articular surface size gh 10 mm height "use with plate 5 cat: 00-5964-042-10 lot: 61625643.Complaint sample was evaluated and the reported event was confirmed.Femoral component confirms scratches/gouging on the medial and lateral condyles.Also, surface at these regions is color buffed.Sem analysis results state ¿from the damage pattern, it appears that articular surface disassociated from the tibial tray and moved in the anterior direction and upwards, allowing the femoral condyle to articulate directly on the tibial tray and overtime, causing depression to be worn into it.The material loss is potentially due to excessive loading on the medial side due to misalignment in vivo.Because of such unusual alignment and loading, it cannot be determined whether the damage is due to wear or fracture, but the compressive strength of the poly material may have been exceeded.Regarding articular surface flaring, it cannot be determined whether this flaring occurred as a result of motion after disassociation from the tibial tray, or was a cause of the disassociation¿.Device history record was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required.Root cause was unable to be determined.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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

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.

• Brand Name: FEM.NG LPS FLEX PRL OPT.M.G DX
• Type of Device: PROSTHESIS, KNEE
• 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: 6324239
• MDR Text Key: 67276393
• Report Number: 0001822565-2017-00806
• Device Sequence Number: 1
• Product Code: NJL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP060037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 00596401752
• Device Lot Number: 60909426
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2008
• 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: 58 YR
• Patient Weight: 129