MAUDE Adverse Event Report: ZIMMER / BIOMET ZIMMER KINECTIV M/L TAPER HIP PROSTHESIS

Catalog Number 00-7848-012-01, 00-7713-007-00

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Necrosis (1971); Toxicity (2333); Joint Dislocation (2374); Osteolysis (2377); Reaction (2414)

Event Date 09/08/2015

Event Type  Injury  

Event Description

I had 4 hip dislocations prior to this surgery date.Starting (b)(6) 2015, (b)(6) 2015, (b)(6) 2015, and one on (b)(6) 2017.All on left side.On (b)(6) 2015, surgery dr (b)(6) exchanges the polyethylene liner, the modular neck, and the femoral head.This was mainly because of all the hip dislocations.There also was a lot of fluid and pieces of plastic in there.On (b)(6) 2016, left hip surgery as i developed some skin reaction on the lower part of my incision.Treated one month with keflex.So on this date (b)(6) 2016 i was undergoing another hip surgery where dr (b)(6) found a lot of fluid again, extensive osteolysis and soft tissue necrosis.He exchanged the polyethylene liner again and the femoral head.He felt it was metallosis and sent me to see dr (b)(6) at (b)(6) on (b)(6) 2016 where i have had mri's left hip, xrays, and cobalt/chromium levels.The last level was extremely elevated.He said surgery has to be done to take the implant out and put new one in.He says it's complex surgery.He stated if i wait, i will not have enough muscle tissue to work with.I am scheduled for (b)(6) 2018 at (b)(6) in (b)(6).This will be the 4th surgery on this hip since it was put in on (b)(6) 2009.I had add'l hip implant surgeries.A component in this hip implant is causing metallosis.Other identifying info: kinective modular neck, modular femoral stem, versys femoral head ref (b)(4).

• Brand Name: ZIMMER KINECTIV M/L TAPER HIP PROSTHESIS
• Type of Device: ZIMMER KINECTIV M/L TAPER HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER / BIOMET
• MDR Report Key: 7600580
• MDR Text Key: 111227030
• Report Number: MW5077843
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/13/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 00-7848-012-01, 00-7713-007-00
• Device Lot Number: 60850265, 60825861, 61138086
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 65 YR
• Patient Weight: 102