MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN STAR TALAR COMPONENT; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME

Catalog Number UNK_SEL

Device Problem Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Arthralgia (2355)

Event Date 03/03/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient presented with ankle pain.X-rays showed a medial mal fracture.

Manufacturer Narrative

Evaluation revealed the tibial component, the sliding core and the talar component to be the subject products.No further associated products were reported.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.In the case presented a female patient had been treated with star in on (b)(6) 2014.Most likely on (b)(6) 2017 the patient was revised as she was having pain in the ankle.The total ankle replacement was removed and replaced with implants not provided.The damage modes of pitting and scratching were observed on the superior and inferior surface of the received sliding core.The inferior surface furthermore exhibited abrasion and deformation marks adjacent to the through, which was likely produced by the contact with the talar component articulating with the bearing surface as opposed to the trough.The tibial- as well as the talar components showed signs of use in the form of scratches, but no significant damage.A region of adhesive transfer with abrasive wear was identified on the tibial- as well as on the talar component.Overall the results of the stage 1 analysis are consistent with well-positioned and well-functioning devices implanted for nearly 3 years.Pain is a known complication, is listed in the ifu as a known adverse effect and had 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.¿ referring to medical opinion of reviewed x-rays the event was caused most likely by patient conditions as non-union was confirmed.This fracture non-union is not due to ankle implant failure.Based on the available information a deficiency of the devices in question could not be verified.The root cause of the pain was most likely patient related.In case any relevant clinical information should become available, we reserve the right to update the investigation and change the root cause.A deficiency of the device(s) was not verified.

Event Description

Patient presented with ankle pain.X-rays showed a medial mal fracture.

• Brand Name: UNKNOWN STAR TALAR COMPONENT
• 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: 6443753
• MDR Text Key: 71200370
• Report Number: 0008031020-2017-00186
• 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: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/29/2018
• Device Catalogue Number: UNK_SEL
• Device Lot Number: 130903/1553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2017
• Initial Date FDA Received: 03/29/2017
• Supplement Dates Manufacturer Received: 07/18/2017
• Supplement Dates FDA Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 110