MAUDE Adverse Event Report: STRYKER GMBH SLIDING CORE UHMPWE, 8MM; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Catalog Number 400142

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Multiple Fractures (4519)

Event Date 01/15/2015

Event Type  Injury  

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.

Event Description

As reported: "i had issues with the star ankle replacement as soon as it was put in.The center piece kept breaking and causing fractures.I had multiple revisions and had to have my leg amputated.".

Event Description

As reported: "i had issues with the star ankle replacement as soon as it was put in.The center piece kept breaking and causing fractures.I had multiple revisions and had to have my leg amputated." per medical records received from the patient on (b)(6) 2021 the event is as follow: (b)(6) 2014 : total ankle implant arthroplasty with insertion of star implant (b)(6) 2015 : anterior ankle arthrotomy with exchange of polyethylene total ankle implant, right ¿ 1st intervention.

Manufacturer Narrative

Corrections: please refer to sections b1, b2 and b5.The reported event could not be confirmed since the device was not returned for evaluation and no x-rays were provided.Operative reports were however provided and analyzed by the medical expert, for each complication reported between 2014 and 2016: "i will try to comment on the procedures that were done in short.Medical interventions : (b)(6) 2014 : total ankle implant arthroplasty with insertion of star implant uncomplicated placement of a total ankle implant, with 3 additional procedures related to nerve entrapments and to gastrocnemius muscle and achilles tendon.(b)(6) 2015 : anterior ankle arthrotomy with exchange of polyethylene total ankle implant, right ¿ 1st intervention revision surgery due to instability and pain.The polyethylene inlay was exchanged, it was displaced.For me it remains unclear from the report whether the inlay was broken or displaced or both.Additional procedures to treat neural pain.Note: a significant amount of yellow discolored synovial-like fluid was noted when the ankle joint was opened (b)(6) 2015 : lateral ankle arthrotomy with bone cultures and irrigation of right ankle- 2nd intervention suspicion of an infected ankle wound and joint.Not evident abscess, many cultures were taken.(b)(6) 2015 : resection tibialis anterior tendon with tibialis tendon transfer ¿ 3rd intervention wound debridement right ankle - intregra matrix graft used this procedure was performed for a non-healing wound.The surgeon mentions the problem is caused by an allergic reaction to exparel.This was used in and around the ankle in the first and third procedure.It was not used in this or the following procedures anymore.(b)(6) 2015 : denervation of superficial peroneal nerve, right ankle ¿ 4th intervention treatment of neural pain of a number of nerves, and treatment of the non-healing wound (b)(6) 2015 : anterior ankle arthrotomy with removal of total ankle implant with bone culture and biopsy.¿ 5th intervention wound healing problems remain and need revision.(b)(6) 2016 : patient fell, twisted ankle, suffered from pain and swelling.Walking boot size med to left foot, discharged to home via wheelchair, with family.As a summary: the patient had a total ankle replacement, a revision was done for instability and pain.The polyethylene inlay was exchanged.Afterwards there were signs of an infection.From the reports it seems to be an inflammatory reaction due to an allergic reaction to exparel.In none of the reports it is mentioned that the cultures came back positive for bacteria or any other infectious agent.An allergic reaction to exparel (or any other drug) can mimic an infectious situation.During the revision (second procedure) it was noted that a lot of synovial fluid was present in the joint.This may have been the first sign of the inflammatory reaction maybe due to exparel.Furthermore, the continuous inflammatory reaction/process may also have caused the neural pain in and around the nerves around the ankle joint.Later serious wound problems occurred, in the fourth report, the allergy is described, exparel was also not used anymore in this or the following procedures.The damage to the wound was already done.In the end the non-healing wound is most likely the cause of the amputation." as a conclusion, the most probable root cause of the amputation reported, based on the information provided in the various reports provided is a patient allergy to exparel, which could have prevented the healing of the wound.The root cause of the breakage of the poly insert could not be determined since no x-rays were provided.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 any further information is provided, the complaint report will be updated.

• Brand Name: SLIDING CORE UHMPWE, 8MM
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11426564
• MDR Text Key: 238342511
• Report Number: 0008031020-2021-00080
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• PMA/PMN Number: P050050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/01/2021

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 Catalogue Number: 400142
• Device Lot Number: 1317094
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 03/07/2021
• Supplement Dates Manufacturer Received: 05/10/2021
• Supplement Dates FDA Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 33 YR
• Patient Weight: 70