MAUDE Adverse Event Report: ZIMMER, INC. NEXGEN PROLONG LPS FLEX ARTICULAR SURFACE SIZE CD 10MM HEIGHT; PROTHESIS, KNEE.

Model Number N/A

Device Problems Material Discolored (1170); Naturally Worn (2988)

Patient Problem No Information (3190)

Event Date 10/28/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products : item name: unknown nexgen femoral component.Item name: unknown nexgen tibial component.

Event Description

It was reported the patient was revised for femoral and tibal loosening.The surgeon noticed staining and wear on the articular surface.

Manufacturer Narrative

The product was returned for further evaluation.Visual inspection exhibits heavy gouging on the proximal surface.The device also exhibits a yellow discoloration that may be associated with oxidation from implantation.The dovetail feature of the articular surface had its dovetail feature flared out, indicating proper insertion technique.The height of the device was measured and was found conforming to print specifications.The device history records were reviewed for the articular surface and its subcomponents and found one deviation, ppdr81.This planned deviation was implemented as an interim control for the issuance of outer cavity at the gas plasma sterilization step.This planned deviation would not have any subsequent effect as it pertains to this event.These products are used for treatment.The devices were reviewed for compatibility.It was found that the articular surface and the femur were not compatible with each other.An internal investigation was initiated for an increased rate of revision in the mis tibia due to loosening.The result of the investigation was the implementation of field action which highly encouraged surgeons to utilize the drop down stem extension and to confirm the proper cementing treatment was used for the mis tibial component.Per the mis tibia surgical technique ¿use of a drop down stem is strongly recommended to provide adjunctive stability to the cemented construct¿.Failing to use a drop down stem extension¿.May lead to early loosening of the prosthesis.¿ additionally per the packaging insert for the articular surface ¿do not use lps or lps-flex femoral components with lps-flex prolong articular surfaces unless the part number of the femoral component has a 51 or 52 part number suffix.Use of other suffix lps or lps-flex femoral components may increase the risk of articular surface spin fracture.¿ therefore, root cause for the associated event is an inappropriate use of the devices.This report is number 3 of 3 mdrs filed for the same patient (reference 0001822565-2017-00093-1/00094-1/00095-1).

• Brand Name: NEXGEN PROLONG LPS FLEX ARTICULAR SURFACE SIZE CD 10MM HEIGHT
• Type of Device: PROTHESIS, 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: 6231412
• MDR Text Key: 64130143
• Report Number: 0001822565-2017-00093
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 00596203010
• Device Lot Number: 61569292
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2016
• Initial Date FDA Received: 01/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: ZFA 2010-013
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 56