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 Codes	Failure of Implant (1924); Injury (2348)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.(b)(6) device disposition unknown.
Event or Problem Description
As reported: "subject received star in the left ankle on (b)(6) 2018 for primary arthrosis, with left gastrocsoleus recession, left distal tib/fib fusion, left placement of medial maleolar screws for prophylaxis for impending medial malleolar fracture, and a separate incision for left secondary lateral ligament reconstruction.Subject was contacted for follow-up and stated that she had her left ankle replacement removed on [(b)(6) 2020] due to device failure.Ae onset date was (b)(6) 2019.The investigator deemed this ae as severe with unknown relationship to the device at the time of this reporting.As of the time of this report, this adverse event is recovered with treatment (surgery: revision/removal of star).".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences 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.As no x-rays, medical records and operation reports were available, a medical review was not possible.It could not be determined whether the implants had been placed according to the anatomical requirements.It could furthermore not be determined if the components had been implanted in the correct position.Regarding the outstanding patient data (e.G.Pre-existing illnesses, unreasonable stresses) it could not be determined if the patient conditions were adequate for the used implant respectively or if potential adverse effects may have contributed to the pain experienced.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device, patient¿s medical records and x-rays must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
As reported: "subject received star in the left ankle on (b)(6) 2018 for primary arthrosis, with left gastrocsoleus recession, left distal tib/fib fusion, left placement of medial maleolar screws for prophylaxis for impending medial malleolar fracture, and a separate incision for left secondary lateral ligament reconstruction.Subject was contacted for follow-up and stated that she had her left ankle replacement removed on [04feb2020] due to device failure.Ae onset date was 12dec2019.The investigator deemed this ae as severe with unknown relationship to the device at the time of this reporting.As of the time of this report, this adverse event is recovered with treatment (surgery: revision/removal of star).".

• 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 ; CH 2545
• MDR Report Key: 9838176
• Report Number: 0008031020-2020-00723
• Device Sequence Number: 1299674
• Product Code: NTG
• UDI-Device Identifier: 00886385016535
• UDI-Public: 00886385016535
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P050050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2020

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: 04/30/2021
• Device Model Number: 400-262
• Device Catalogue Number: 400262
• Device Lot Number: 1449087
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 04/21/2020
• 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: 68 YR
• Patient Weight: 95