MAUDE Adverse Event Report: ZIMMER CRUCIATE RETURNING FEMORAL COMPONENT POROUS SZ E RIGHT

Catalog Number 5972-15-02

Device Problems Break (1069); Inadequacy of Device Shape and/or Size (1583); Device Slipped (1584)

Patient Problems Fall (1848); Pain (1994); Injury (2348); Inadequate Pain Relief (2388)

Event Date 10/09/2013

Event Type  Injury  

Event Description

Dr (b)(4), hospital - (b)(4), implant record - (zimmer nexgen complete knee solution), cruciate retaining articular surface size green/c-h 10mm height plate 5.6 ref no.90-5970-40-10 lot 61470396 edi 90597004010; stemmed tibial component precoat size 5 ref no.5980-47-01 lot 61514025 edi 00599004701; cruciate retaining femoral component porous size e right ref no.5972-15-02 lot 61501594 edi 00597201502; stryker bone cement orthopaedics full dose usa ref no.6191-1-001 lot rfr112.I had more pain than i did before that total replacement and looseness knee turning more than one inch each way.I was told by dr (b)(6) this is normal circumstance.I had to see my general practitioner after he released med with a light duty only diagnosis because i couldn't continuously stand up nor was i stable.I experienced unnatural instability.I suffered continuously w/o the doctor sharing that there was a zimmer warning and recall, even though my wife specifically asked him the day before my surgery, "is there anything i should know about this product?" i sought medical treatment for pain with my general practitioner dr (b)(6) family medicine on (b)(6) from the time i was released from dr (b)(6) until changing to (b)(6) 2013.I saw pa (b)(6) hospital who identified and confirmed i was having serious symptoms consistent to those reported by fda on other zimmer total knee replacements.At first, i had no idea there were reoccurring life threatening symptoms leading to me needing a total revision.No one should be left in this amount of pain.I experienced instability, uncontrolled pain and could not stand for long periods of time w/o falling-injuries.I never was able to return to work because the prosthetic was faulty from the start.My first orthopedic doctor lead me to believe these symptoms were ordinary.I dealt with it as best i could, but never understood what was happening to my leg until after i rec'd surgery notes from my revision dated (b)(6) 2013.On (b)(6) 2013, pa (b)(6) sent me to dr (b)(6) orthopedist, (b)(6) who took x-rays and cat scan (b)(6) 2013.The serious nature of my condition was confirmed by dr (b)(6) and dr (b)(6) orthopedists.My symptoms matched other product failure from zimmer knee replacement prosthetics currently in fda recall.I under went total knee revision (b)(6) 2013 reconstructed by dr (b)(6).Dr (b)(6) called upon a second his peer to confirm the x-rays and a cat scan taken by (b)(6) determined showed the distal tibial tray was under sized.Specifically- (report dated (b)(6) 2013).The lateral x-ray showed femoral notching resulting is loss of stability, loosening of prosthetic and chronic uncontrolled pain.Total revision (b)(6) 2013 treated by dr (b)(6).Pre-operative reports indicated the cement had broken loose causing instability, the pain was substantiated by his x-rays.Upon having the revision, dr (b)(6) operative report declared the first surgery failed.His report defines the changes (all components) and finding all zimmer components faulty.I am reporting to you the product first used in my right knee was to have lasted 10 to 15 yrs, but was failing almost immediately.If my first orthopedic doctor, (b)(6), would have been forthright with me when he defined the loosening i would have contacted you earlier.He chose to let me suffer.Please contact me at your earliest convenience (b)(6).It is clear these products need to be added to your recall list.All treatments are documented and are ready for your viewing.I need to know if these components are on your recall or if you are taking action to add them to your list of prematurely breaking and becoming faulty in need of replacement.

• Brand Name: CRUCIATE RETURNING FEMORAL COMPONENT POROUS SZ E RIGHT
• Type of Device: FEMORAL COMPONENT
• Manufacturer (Section D): ZIMMER
• MDR Report Key: 3612673
• MDR Text Key: 17264859
• Report Number: MW5034217
• Device Sequence Number: 4
• Product Code: HSA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/03/2014
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5972-15-02
• Device Lot Number: 61501594
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 49 YR
• Patient Weight: 68