MAUDE Adverse Event Report: ZIMMER, INC. - BUILDING 5 GENDER SOLUTIONS NATURAL-KNEE FLEX PROLONG ARTICULAR SURFACE; KNEE PROSTHESIS

Model Number N/A

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Scratched Material (3020)

Patient Problem Pain (1994)

Event Date 02/26/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the patient was revised due to pain and the articular surface dislodging.

Manufacturer Narrative

This report is being amended to reflect changes.

Manufacturer Narrative

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

Manufacturer Narrative

Visual inspection of the returned articular surface confirms that the locking tab has fractured off.The fractured off tab was not returned.There are also signs of damage on the distal surface and scratches/gouges on the proximal surface of the articular surface.The femoral component and the tibial tray were also returned.Review of the device history records for the articular surface product part and lot numbers identified no deviations or anomalies.The work order number, which is the rework order lot number, was also reviewed and found no deviations or anomalies.The knee implant compatibility matrix for components was reviewed and identified there were no compatibility issues noted for the full construct.This device is used for treatment.A product history search conducted for the articular surface identified no other complaints for this part and lot combination.It is reported that the patient underwent revision surgery of the left knee on (b)(6) 2016 due to dislocation of the articular surface.The patient reported that the articular surface dislodged and ended up under her patella.The patient had a left knee exam approximately a month before the revision surgery ((b)(6) 2016), as she was concerned about noise and cracking.This exam revealed that there was no swelling or effusion, good straight leg raise, full extension, possibly 1 or 2 degrees of hyperextension, some lateral scar tissue popping, no patellar clunk, and x-rays of the knee looked good.Notes from a day before the revision surgery ((b)(6) 2016) indicate that 3 days before the revision ((b)(6) 2016), the patient began to have cramping in her left calf during the middle of the night.She got up to attempt to walk it off.While attempting to get out of bed, she slightly twisted her left knee.At this time, she began to have excruciating left knee pain with inability to tolerate any weight bearing.The operative notes from the revision surgery on (b)(6) 2016 indicate that the locking mechanism of the articular surface had failed on the insert, and the articular surface was displaced.Along with the articular surface, the femoral and tibial components were also revised.The patella was not revised.The risks of dislocation and device fracture are addressed in the gender solutions natural-knee flex system package insert, as a part of design control risk management.The package insert lists ¿dislocation and/or joint instability¿ and ¿loosening or fracture/damage of the prosthetic knee components or surrounding tissues¿ as adverse effects.These are therefore known inherent risks of receiving this implant.A definitive root cause cannot be determined with the information provided.

• Brand Name: GENDER SOLUTIONS NATURAL-KNEE FLEX PROLONG ARTICULAR SURFACE
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC. - BUILDING 5; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: kathleen smith ; p.o. box 708; warsaw, IN 46580-0708 ; 8006136131
• MDR Report Key: 5608685
• MDR Text Key: 43659596
• Report Number: 0001822565-2016-01325
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00542801016
• Device Lot Number: 60853855N
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2013
• 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): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 113