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

Catalog Number 400263

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 02/13/2017

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.(b)(4).

Event Description

Patient had significant pain and is non weight bearing.X-ray showed medial and lateral fractures.Decision was made to convert to ttc.

Manufacturer Narrative

Evaluation revealed the talar comp, the tibial comp and the sliding core to be the subject products.No further associated products were reported.In the case presented a patient had been treated with star on (b)(6) 2010 due to a severe arthrosis of the left ankle and hindfoot.On (b)(6) 2017 the patient presented to the clinic for evaluation of her left foot.She stated to have significant pain.She is nonweight bearing in a cam walker.X-rays showed a fracture of her medial malleolus with varus displacement.The radiographs furthermore showed a fracture of her fibula.Her foot is resting in varus and is unstable.She can¿t put any weight down on it.The attending surgeon decided that she is going to require a surgical procedure to address this.She will need a tibiotalocalcaneal arthrodesis (ttc / fusion of the tibia, talus and calcaneal bone) with femoral head allograft.A review of the device history records for the tibial component and sliding core revealed no discrepancies.Deficiency in material or manufacturing was not found.The affected items were documented as faultless prior to distribution.Thus, we excluded deviations in material and manufacturing.The device history of the talar component could not be reviewed as the serial number was no longer legible.The damage modes of pitting and scratching were observed on the superior and inferior surface of the received sliding core.A significant damage could not be found.The tibial- as well as the talar component showed signs of usage and implantation in the form of scratches, but no significant damage.A region of adhesive transfer with abrasive wear was identified on the tibial component.Adhesive transfer with abrasive wear was also identified on the talar component.Bone fracture is a known complication, which is listed in the ifu as a known adverse effect.It has been clinically assessed by a consultant hcp: postoperative stress fractures, mostly of the medial and lateral malleoli, are rare events.Stable undisplaced fractures (fissures) usually do not require specific surgical measures, whereas unstable displaced fractures require internal fixation (mostly with interfragmentary screws or plate fixation of the lateral malleolus).Such fractures have low impact on the clinical outcome because they normally consolidate after a short period of immobilization and reduction of weight bearing.Based on the available information a deficiency of the devices in question could not be verified.In case any relevant clinical information should become available, we reserve the right to update the investigation and change the root cause.Review of complaint history, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject products.No non-conformity was identified.

Event Description

Patient had significant pain and is non weight bearing.X-ray showed medial and lateral fractures.Decision was made to convert to ttc.

• Brand Name: TIBIAL COMP,SINGLECOATED US VERSION, 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6401145
• MDR Text Key: 69842902
• Report Number: 0008031020-2017-00125
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2014
• Device Catalogue Number: 400263
• Device Lot Number: 090807 / 2194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2009
• 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): Required Intervention