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

Model Number	400-263
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	09/05/2017
Type of Reportable Event	Serious Injury
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.Pain is a known complication, listed in the ifu as a known adverse effect and had been clinically assessed by a consultant hcp: ¿in most cases ankle arthroplasty comes with significant pain relief.Approx.60 % ¿ 80 % of the patients are pain free or nearly pain free in the follow up, approx.20 % ¿ 30 % have moderate pain (e.G.Starting pain), but less than 10 % of the patients have remaining pain or symptomatic pain due to a malpositioning or a malfunction of the endoprosthesis or due to additional arthrosis of the adjacent joints (mostly in rheumatoid arthritis) or soft tissue affections.Treatment is depending on the particular reason for pain.¿ 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 positions.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 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.Device is not available for return, device is still implanted.
Event or Problem Description
Patient received star in the right ankle on (b)(6) 2017 for primary arthrosis.Patient presented with pain, described as swelling in the ankle on (b)(6) 2017.The investigator deemed this ae as moderate and possibly related to the device.At the time of this report, this adverse event is ongoing and continuing without treatment.

• Brand Name: TIBIAL COMP,SINGLECOATED US VERSION, LARGE
• Common Device Name: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9845493
• Report Number: 0008031020-2020-00727
• Device Sequence Number: 2636747
• Product Code: NTG
• UDI-Device Identifier: 00886385016542
• UDI-Public: 00886385016542
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P050050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/17/2020

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: 05/31/2020
• Device Model Number: 400-263
• Device Catalogue Number: 400263
• Device Lot Number: 1507066
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 03/17/2020
• 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: Other
• Patient Age: 71 YR
• Patient Weight: 64