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

Model Number	400-262
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/18/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded.
Event or Problem 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 march 25th, 2021.The event is as follow: (b)(6) 2015 : lateral ankle arthrotomy with bone cultures and irrigation of right ankle - 2nd intervention.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.The medical opinion of a medical expert was requested based on the provided patient documents that we have received.About this complaint, the medical expert explained that: "(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." this statement allowed us to determine that this complaint is about an infection case.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 infection.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.
Event or Problem 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) 2015 : lateral ankle arthrotomy with bone cultures and irrigation of right ankle - 2nd intervention.

• Brand Name: TIBIAL COMP,SINGLECOATED US VERSION, MEDIUM
• Common Device Name: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11679287
• Report Number: 0008031020-2021-00165
• Device Sequence Number: 3511367
• Product Code: NTG
• UDI-Device Identifier: 00886385016535
• UDI-Public: 00886385016535
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P050050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/31/2019
• Device Model Number: 400-262
• Device Catalogue Number: 400262
• Device Lot Number: 1407206
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR
• Patient Weight: 70