MAUDE Adverse Event Report: STRYKER GMBH SLIDING CORE, UHMPWE,6M (STERILE PACKAGED); PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Catalog Number 400140F

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyst(s) (1800); Injury (2348)

Event Date 06/24/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient's left ankle will be revised due to the presence of cysts.The surgeon's plan is to perform removal of the cysts and exchange of the poly.Revision surgery is scheduled for (b)(6) 2020.

Event Description

It was reported that the patient's left ankle will be revised due to the presence of cysts.The surgeon's plan is to perform removal of the cysts and exchange of the poly.Revision surgery is scheduled for (b)(6) 2020.

Manufacturer Narrative

Correction: please note that the device was returned and evaluated.The reported event could be confirmed.The customer requested to know if the patient tissue provided showed presence of polyethylene particles.The polyethylene component has been returned and shows a slight deformation on either the medial or the lateral side but is not broken and could overall be considered to be in a good state.A histology analysis was performed by an independent laboratory to evaluate peri-implant tissues retrieved from the 70-year-old male patient.The analysis could confirm the presence of birefringent particles within macrophages, and within the occasional giant cells.No black particles were seen within any of the tissues.However, the birefringent particles could not be confirmed as polyethylene for certain.Furthermore, a literature review was performed and shows that macrophage triggered immune response to metal and polyethylene wear particles which results in large progressive lesions and cysts in the periarticular tissues, whereas the formation of nonprogressive cysts have been observed in cases of bone remodeling and stress shielding after implant insertion [1].In symptomatic patients, prompt intervention, such as bone grafting and curettage of cysts is required to avoid implant failure and loosening [2].Bonnin et al., reported 22% of cases (19 ankles) to show talar or tibial cysts >5 mm by ct at an average follow up of 8.9 years on 87 taas [3].Good clinical outcome and cyst resolution was achieved by polyethylene exchange, packing with autograft and curettage of cysts in 8 patients [2].As a conclusion, cyst formation is a natural and predictable reaction of the body following a joint replacement.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.[1] g.-p.F.Arcângelo j, pinto a, grenho a navarro a, martin oliva x., "peri-prosthetic bone cysts after total ankle replacement.A systematic review and meta-analysis," foot ankle surg, vol.25, no.2, pp.96-105, (b)(6) 2019, internal-pdf://arcangelo_2019_foot ankle surg_29409184.Pdf.[2] a.R.Hsu, s.L.Haddad, and m.S.Myerson, "evaluation and management of the painful total ankle arthroplasty," (in english), j am acad orthop surg, vol.23, no.5, pp.272-82, (b)(6) 2015, internal-pdf://evaluation and management of the painful total ankle arthroplasty.Pdf.[3] s.Dhar, d.Sunderamoorthy, and h.Majeed, "cysts: osteolysis and stress shielding; more than just filling a void," total ankle arthroplasty - chapter american academy of orthopaedic surgeons, pp.197-209, 2015, internal-pdf://dhar_2015_american academy of orthopedic surgeons.Pdf.

• Brand Name: SLIDING CORE, UHMPWE,6M (STERILE PACKAGED)
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10299963
• MDR Text Key: 199991616
• Report Number: 0008031020-2020-01934
• Device Sequence Number: 1
• Product Code: NTG
• 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: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: 400140F
• Device Lot Number: 1415140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention