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

Catalog Number UNK_SEL

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

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 & 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 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&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 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

Correction in mfr site.

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 & 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&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 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.

• Brand Name: UNKNOWN STAR ANKLE 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: 6308579
• MDR Text Key: 66722051
• Report Number: 0008031020-2017-00056
• 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: 02/07/2017

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: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2017
• 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