MAUDE Adverse Event Report: ENCORE MEDICAL L.P SLIDJNG CORE, UHMPWE,8MM; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Catalog Number 400-142F

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

Patient Problem Implant Pain (4561)

Event Date 03/01/2024

Event Type  Injury  

Manufacturer Narrative

It was reported that part 400-142f, 7mm sliding core star total ankle, was explanted due to patient pain.Independent sales representative stated "when they went to remove it, the poly (400-142f) was in two separate pieces.It had split along the ridge where the keel rests.Doctor didn't know if it was split as a result of trying to remove it, or if that was causing the patient pain in the first place." additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Event Description

It was reported that part 400-142f, 7mm sliding core star total ankle, was explanted due to patient pain.Independent sales representative stated "when they went to remove it, the poly (400-142f) was in two separate pieces.It had split along the ridge where the keel rests.Doctor didn't know if it was split as a result of trying to remove it, or if that was causing the patient pain in the first place.".

Manufacturer Narrative

There were 7 similar complaints identified for star poly components breaking.Dhr review was not conducted due to the complaint part not being returned and the lot number remaining unknown.It is unknown if the doctor followed the surgical technique with the limited information available.The poly was not returned so visual and dimensional inspection did not occur.Simulated use testing did not occur with the poly being implanted for an unknown amount of time.The reporter stated the poly swap was due to patient pain.The reporter also stated "when (the surgical team) went to remove it, the poly was in two separate pieces.It had split along the ridge where the keel rests.Doctor didn't know if it was split as a result of trying to remove it, or if that was causing the patient pain in the first place.Based on the limited information, and the poly not being returned, the root cause shall remain as unknown.Part / lot number(s) unknown or could not be narrowed down.The explanted poly was identified as 400-141f, (sliding core, uhmpwe, 7mm).With the information available and provided by the reporter, the lot number was unable to be identified.Thus, dhr review was unable to occur.Simulated use not conducted for either returned device(s) nor with similar parts.The construct has been implanted for an unknown amount of time, so simulated use testing would not be able to accurately recreate the physiological changes that occurred during implantation.The overall risk is high with a risk index of 3.Severity level of 4 (significant) is appropriate as there could be permanent functional impairment of body function and the failure may occur with or without warning.It was determined that 688 tibial polymer components (pn:400-14x) were sold between march 2023 and march 2024.With 8 reported events of star poly damage, the occurrence rate is 1.16%.Thus, an occurrence level of 5 (frequent/high) is appropriate.Per rf-str-0001 revision 3 risk benefit analysis for u23.2, "every endoprosthesis has a limited lifespan.With state of the art techniques, there is no potential for further mitigation of the risks from a clinical point of view".Therefore, the risk shall remain appropriate.

• Brand Name: SLIDJNG CORE, UHMPWE,8MM
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 19056506
• MDR Text Key: 339551324
• Report Number: 1644408-2024-00393
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 400-142F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 04/06/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female