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	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	06/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
Event or Problem Description
A patient reported via medwatch mw5102110 that they had a star ankle replacement in 2013.Pain had steadily increased over the last six months.The doctor had to perform a polyethylene replacement (b)(6) 2021.The original insert was potentially broken.
Additional Manufacturer Narrative
Please note corrections to section d4 lot#; the lot 1106022660 was communicated.However, this lot did not yield any results in our databases, and does not look like a typical lot for star prosthesis.Therefore, the lot in this case will be considered unknown.The reported event could not be confirmed since the device was not returned for evaluation and recent x-rays were not provided.Since x-rays were provided, the opinion of a medical expert was requested.Their opinion is as follows : "looking at the reports from the surgeon and the photo¿s i can give my opinion on the fracturing op the polyethylene core of the star ankle prosthesis.The patient visited his surgeon recently with pain in the ankle, eight years after the initial ankle replacement.The pain became worse over the last 6 months.Unfortunately there is no additional information from 2021 for this case.The reports and x-rays are from 2013-2014 only.Revision surgery after ankle replacement is not uncommon.Unfortunately it is more common than in hip and knee.Probably the wear and tear in the ankle is higher, also because of the complex movement in the ankle.The polyethylene core is exchanged after fracturing most often, but some surgeons replace it if revision is needed (also for other components) just to place a newer generation polyethylene core in the ankle.Poly breakage is a multi-factorial problem in general.It may have to do with the surgery but patient characteristics are also an important factor to weigh in, in this case the patients obesity may have contributed to additional wear of the poly.Looking at the literature, the mean time for polyethylene core fractures to occur is around 5-7 years, however the range is wide, from just over 1 year to 10 years.In this case it was 8 years, which is unfortunate for the patient.I do not see a clear clinical or surgical explanation for the occurrence of this polyethylene core fracture at this time from the attached information." therefore, 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.A review of the device history was not possible because the (right) lot number was not communicated.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
A patient reported via medwatch mw5102110 that they had a star ankle replacement in 2013.Pain had steadily increased over the last six months.The doctor had to perform a polyethylene replacement (b)(6) 2021.The original insert was potentially broken.

• 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 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12668701
• Report Number: 0008031020-2021-00438
• Device Sequence Number: 4161853
• Product Code: NTG
• UDI-Device Identifier: 00886385016542
• UDI-Public: 00886385016542
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P050050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: 400-263
• Device Catalogue Number: 400263
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 82 KG