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

Catalog Number UNK_SEL

Device Problems Fracture (1260); Loose or Intermittent Connection (1371); Loss of Osseointegration (2408)

Patient Problems Failure of Implant (1924); Pain (1994); Synovitis (2094); Ambulation Difficulties (2544)

Event Date 12/01/2018

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device implanted in patient.

Event Description

Patient called stating he had an ankle surgery around (b)(6) 2012.He stated about a month ago he started experiencing difficulty walking.Patient also stated he had x-rays done which show loosening and a gap in between the implant and the bone.Patient is not scheduled for a revision surgery yet.

Manufacturer Narrative

B1 - updated to indicate product problem; b3 - event date updated; b5 - amended to indicate revision surgery was performed the reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information are required in order to determine the exact root cause of the event.In the case presented a male patient had been treated with star in 2012.On (b)(6), 2018 the patient complained of pain in the ankle probably due to the loosening of the implant.Overall the results of the stage 1 analysis are consistent with well-positioned and well-functioning devices implanted for approximately 6 years.Since no x-rays post-implantation were provided, it could not be determined whether the implants had been placed according to the anatomical requirements.It could furthermore not be determined if the components had been implanted in the correct positions.Regarding the outstanding patient data (e.G weight, height, pre-existing illnesses, unreasonable stresses) it could not be determined if the patient conditions were adequate for the used implant respectively if potential adverse effects may have contributed to the pain experienced.Since operative reports were provided, the opinion of a medical expert was requested: " [.] there seems to be missing a lot of valuable info, i don¿t know whether the info is present or not.[.] time line: (b)(6)2021: total ankle replacement on the left after an earlier lower leg fracture with post traumatic arthritis nothing special in the operative report or the post-operative x-ray (b)(6)2012: apparently there were issues with a growing pulsating mass near the operated ankle, a pseudoaneurysm was shown via additional examination (post-operative vascular complication? not related to the implant but to the procedure).(b)(6)-2012: vascular surgery on the left ankle for the treatment of the pseudoaneurysm.2014: talar # on the left? (mentioned in additional examination in 2015, however no information on this fracture is to be found anywhere (treatment? result? follow-up? consequences for the implant?) 2015: additional radiological examinations showing ossification of the syndesmosis and no apparent problems with the prosthesis.(no additional mention about the healing of the talar fracture or associated problems? after this no more information is found in the current (incomplete?) medical file.[.]" based on the above statement, more information such as x-rays, and device details is needed in order to determine a root cause for the event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

Patient called stating he had an ankle surgery around (b)(6), 2012.He stated about a month ago (december 2018) he started experiencing difficulty walking.Patient also stated he had x-rays done which show loosening and a gap in between the implant and the bone.The patient was revised on (b)(6), 2019, where it was found the star poly component was broken in half, significant ankle synovitis.

• Brand Name: UNKNOWN STRYKER ANKLE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 8351740
• MDR Text Key: 136587747
• Report Number: 0008031020-2019-00068
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: 090319
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 83