MAUDE Adverse Event Report: STRYKER GMBH TIBIAL COMP,SINGLECOATED US VERS, X-LARGE; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME

Catalog Number 400264

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 10/14/2015

Event Type  malfunction  

Manufacturer Narrative

Device remains implanted.Additional information was requested and if received will be provided on a supplemental report.Product inquiry stated the tibial comp, single coated us vers, x-large, the sliding core, uhmpwe, 9mm and the talar comp, single coated us vers medium, left to be the subject products.No further associated products were reported.The affected items were documented as faultless prior to distribution.Thus, we excluded deviations in material and manufacturing.A physical examination could not be carried out as the devices were not available for evaluation (were still implanted).Thus, a reasonable examination and investigation was not possible.Referring to the event description a ¿radiolucency (7mm) was observed¿.Cysts in general had been experienced and are nominated in the scientific literature.It does not present an unanticipated event in itself.¿the by-products of frictional wear between the metal and polyethylene components of joint replacements lead to peri-prosthetic bone resorption.This process is named osteolysis and can result in subclinical or significant bone loss, loss of implant stability, subsidence, and implant failure¿ ¿early recognition, monitoring, and treatment of progressive peri-prosthetic osteolysis may prevent loss of implant stability.Debridement of the cyst and grafting, correction of malalignment if present, and polyethylene exchange may arrest progressive osteolysis and should be performed before implant failure.¿ cysts were furthermore clinically assessed by a hcp: ¿cyst formation is a typical complication of ankle arthroplasty and probably caused by bone modelling according to the flux of force inside the bone structure related to the implant contact¿.(4) ¿spontaneous bone resorption and cyst formation represents a significant problem in ankle arthroplasty.The symptoms may be mild and will not require specific surgical measures, but in many cases revision surgery with bone grafting may be required.In advanced cases cyst formation may cause a collapse of the arthroplasty requiring implant removal and ankle fusion¿.(4).Based on the above information, a deficiency of the devices in questions was not verified.Nevertheless as the exact cause of cyst formation is still poorly explained / understood and probably multifactorial, a correlation between implants and cyst formation could not be excluded.In case any relevant clinical information or the implants should become available, we reserve the right to update the investigation and change the root cause.Osteolysis and/or other periprosthetic bone loss (like cysts) are listed in the ifu as adverse effects.Device remains implanted.

Event Description

Radiolucency (7mm) was observed on star tibial component.No treatment.

• Brand Name: TIBIAL COMP,SINGLECOATED US VERS, X-LARGE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5521064
• MDR Text Key: 41307971
• Report Number: 0008031020-2016-00150
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 400264
• Device Lot Number: 130409/0134
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 95