MAUDE Adverse Event Report: STRYKER GMBH TIBIAL COMP,SINGLECOATED US VERSION, LARGE; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Catalog Number 400263

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 12/20/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported from the clinical team that the subject received a star in the left ankle on (b)(6) 2017.On (b)(6) 2018, subject presented with left talar subsidence with subtalar cystic change resulting in device subsidence.The clinical investigator deems this ae as severe and related to the device.The subject is expected to receive surgical intervention for her left ankle in the coming months.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device and medical records must be available in order to determine the root cause of the complaint event.The device inspection was not possible as the product was not returned for investigation.Cysts (osteolysis), pain and implant dislocations are listed as adverse effects in the ifu; furthermore, a warning regarding activities like running and jumping as a potential cause for implant failures.In addition, patient has a bmi of 43.9 and is obese.The misalignment was most likely caused by the cysts.A correlation between the implants and the cyst cannot be excluded.Cysts and implant dislocations are classified as known adverse effect.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 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

It was reported from the clinical team that the subject received a star in the left ankle on(b)(6)2017.On(b)(6)2018, subject presented with left talar subsidence with subtalar cystic change resulting in device subsidence.The clinical investigator deems this ae as severe and related to the device.The subject is expected to receive surgical intervention for her left ankle in the coming months.

• Brand Name: TIBIAL COMP,SINGLECOATED US VERSION, LARGE
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8579885
• MDR Text Key: 144093886
• Report Number: 0008031020-2019-00392
• Device Sequence Number: 1
• Product Code: NTG
• UDI-Device Identifier: 00886385016542
• UDI-Public: 00886385016542
• Combination Product (y/n): N
• PMA/PMN Number: P050050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 400263
• Device Lot Number: 1446086
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 102