MAUDE Adverse Event Report: ZIMMER, INC. GENDER SOLUTIONS N-K FLEX GSF SINTERLOCK POROUS COATED FEMORAL COMPONENT; KNEE PROSTHESIS

Model Number N/A

Device Problems Unstable (1667); Metal Shedding Debris (1804); Malposition of Device (2616)

Patient Problems Reaction (2414); No Code Available (3191)

Event Date 07/19/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.Product received but not yet evaluated.

Event Description

It is reported that the patient underwent knee arthroplasty revision surgery due to instability.During the procedure malpositioning and metallosis were identified.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical product: gender solutions natural-knee flex prolong polyethylene articular surface, catalog#: 00542402109, lot#: 62157429 natural-knee ii stemmed tibial baseplate porous coated, catalog#: 621201220, lot#: 62193473 multiple mdr reports were filed for this event, please see associated reports: 0001822565-2016-02803, 02805, 02804.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned products were performed.The returned articular surface exhibit heavy damage and wear on the surface and also there is damage to the locking tab.There was damage on the rails of the returned tibial surface.Scratches and gouges were noted on the colour buffed surface of the returned femoral component.Review of x-rays identified that there is overriding of femoral and tibial components - appear superimposed from the ap view but the lateral view x-ray does not suggest any malpositioning.As we don't know the exact time frame of the x-rays, this cannot be confirmed.Review also noted that presence of vague lucency surrounding the tibial hardware stem suggesting an assumption of developing osteoporosis.Also the metallosis could not be confirmed based on the x-rays provided and there was no sign of any noticable joint effusion, soft tissue swelling or metallic debris surrounding the joint.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined.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: GENDER SOLUTIONS N-K FLEX GSF SINTERLOCK POROUS COATED FEMORAL COMPONENT
• 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: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5876612
• MDR Text Key: 52116671
• Report Number: 0001822565-2016-02804
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK071107
• 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
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00541601602
• Device Lot Number: 62224243
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2012
• 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