MAUDE Adverse Event Report: STRYKER GMBH TALAR COMP,SINGLE COATED US VERS SMALL, LEFT; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME

Catalog Number 400255

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 02/06/2017

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.(b)(4).

Event Description

Explant of star and conversion to ttc fusion with t2 ankle nail.Patient was revised due to pain.

Manufacturer Narrative

Evaluation revealed the tibial component, the talar component and the sliding core to be the subject products.No further associated products were reported.In the case presented a female patient had been treated with star in 2002 due to an arthritis of her left ankle.The patient returned to the clinic on (b)(6) 2016 for a follow up examination.The patient stated to have pain in her ankle with weight bearing.The ct scan, which was performed on (b)(6) 2016 indicated the tibial component to be loose.To address the given degree of pain, the attending surgeon suggested an explantation, removal of the hardware and a tibio-talo-calcaneal (ttc) with femoral allograft.The patient was revised on (b)(6) 2017.A review of the device history records 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 damage modes of pitting and scratching were observed on the superior and inferior surface of the received sliding core.A significant wear or damage could not be found.Overall the received item was found to be in a very good condition.The tibial- as well as the talar component showed signs of use and implantation in the form of scratches, but no significant damage.Pain and implant loosening are known complications, which are listed in the ifu as a known adverse effect.They have been clinically assessed by a consultant hcp: ¿in most cases ankle arthroplasty comes with significant pain relief.Approx.60 % ¿ 80 % of the patients are pain free or nearly pain free in the follow up, approx.20 % ¿ 30 % have moderate pain (e.G.Starting pain), but less than 10 % of the patients have remaining pain or symptomatic pain due to a malpositioning or a malfunction of the endoprosthesis or due to additional arthrosis of the adjacent joints (mostly in rheumatoid arthritis) or soft tissue affections.Treatment is depending on the particular reason for pain.¿ ¿septic and aseptic implant loosening is the main failure mode in total arthroplasty of the ankle joint.Depending on the individual kind of failure, it is possible to revise the endoprosthesis and to exchange the affected component(s) or the endoprosthesis has to be re-moved and ankle fusion has to be performed either fixed internally with screws or plates or externally fixed.¿ 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 product.No non-conformity was identified.

Event Description

Explant of star and conversion to ttc fusion with t2 ankle nail.Patient was revised due to pain.

• Brand Name: TALAR COMP,SINGLE COATED US VERS SMALL, LEFT
• 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 TRAUMA KIEL; prof. kuentscher-strasse 1-5; postfach; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6370295
• MDR Text Key: 68751219
• Report Number: 0008031020-2017-00102
• 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: 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2004
• Device Catalogue Number: 400255
• Device Lot Number: 140299/632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/1999
• 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
• Patient Age: 64 YR