MAUDE Adverse Event Report: STRYKER GMBH SLIDING CORE UHMPWE, 7MM; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME

Catalog Number 400141

Device Problems Collapse (1099); Material Integrity Problem (2978)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 01/11/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a caller who indicated that he was a patient of dr.(b)(6) and that he had a star® ankle implanted ¿4 years ago¿ by dr.(b)(6).He had x-rays done in 2014 and 2016, the comparison of which show a ¼¿ drop of the implant so that the implant is ¿collapsing through the talus, almost into the calcaneous¿.He referred to the current status as a ¿failed implant¿ and stated that he was looking for any information (b)(4) could provide re: mri scans that could be done with the star® ankle without excessive artifact ¿to see how much bone is there¿.He said that dr.(b)(6) says he has avn.He saw dr.(b)(6) today (another (b)(4) consultant) who would not say he had avn, but indicated he had ¿site stress¿ with the implant.Finally, a ct scan he recently had done is apparently inconclusive as to whether avn exists at the site update: as per patient, he is experiencing issues with his left ankle.Dr.(b)(6), ct scan as well as three other surgeons' confirmed that his ankle implant is collapsing through the gaous into the subtalar joint and approaching the calcaneus heel.Patient cannot walk as it hurts him.His mobility is very low, walking around is very painful.Pain started last couple of years and has gotten worse.

Manufacturer Narrative

Evaluation revealed the talar component, the sliding core and the tibial component to be the subject products.No further associated products were reported.A review of the device history records could not be carried out as the lot codes were not available.A physical examination could not be carried out as the devices were not available for evaluation as they remained implanted.Thus a reasonable examination and investigation was not possible.In the case presented a patient had been treated with star on (b)(6) 2012 due to an advanced arthritis of the left ankle joint.The following information was received from the patient.He had x-rays done in 2014 and 2016.The comparison of those showed a one quarter drop of the implant so that the implant is collapsing through the talus, almost into the calcaneus.He furthermore stated that his attending surgeon diagnosed an avascular necrosis (avn).When he saw another surgeon, he did not share that opinion, but indicated that the patient might have site stress with the implant.Finally a ct scan had been performed, which was inconclusive as to whether an avn exists at the site.As per patient, four surgeons and the ct scan confirmed that his ankle implant is collapsing through the gaus into the subtalar joint and approaching the calcaneus heel.Medical records such as the surgery report, office notes and x-rays were provided, but only for the timeframe 2010 to 2014.The x-rays performed in 2016 showing the implant drop, were not provided.The images of the recently performed ct scan were also not available.All available medical information were forwarded to a health care professional for review.He stated: i am only seeing reports and radiographs from 2012- 2014, nothing recent.I see no collapse on the early views attached.With available information and radiographs the reported event (¼ drop of the implant / avn) could not be confirmed.More recent x-rays and ct images are required for a precise medical evaluation.The exact root cause could not be determined.With available information a deficiency of the devices could not be verified.The file will be closed formally.In case relevant clinical information or the items 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.

Event Description

It was reported that a caller who indicated that he was a patient of dr.(b)(6) and that he had a star® ankle implanted ¿4 years ago¿ by dr.(b)(6).He had x-rays done in 2014 and 2016, the comparison of which show a ¼¿ drop of the implant so that the implant is ¿collapsing through the talus, almost into the calcaneus¿.He referred to the current status as a ¿failed implant¿ and stated that he was looking for any information syk could provide re: mri scans that could be done with the star® ankle without excessive artifact ¿to see how much bone is there¿.He said that dr.(b)(6) says he has avn.He saw dr.(b)(6) in (b)(6) today (another syk f and a consultant) who would not say he had avn, but indicated he had ¿site stress¿ with the implant.Finally, a ct scan he recently had done is apparently inconclusive as to whether avn exists at the site update: as per patient, he is experiencing issues with his left ankle.Dr.(b)(6) ct scan as well as three other surgeons' confirmed that his ankle implant is collapsing through the gaus into the subtalar joint and approaching the calcaneus heel.Patient cannot walk as it hurts him.His mobility is very low, walking around is very painful.Pain started last couple of years and has gotten worse.

• Brand Name: SLIDING CORE UHMPWE, 7MM
• 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: 6309177
• MDR Text Key: 66762589
• Report Number: 0008031020-2017-00059
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 400141
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 68 YR
• Patient Weight: 86