MAUDE Adverse Event Report: ENCORE MEDICAL L.P SLIDING CORE, UHMPWE, 7MM; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Catalog Number 400-141F

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

Patient Problem Failure of Implant (1924)

Event Date 10/02/2023

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery, on (b)(6) 2023, customer care representative, emailed a delivered goods form for a star total ankle revision surgery to fa complaints inbox.The star total ankle revision case was a poly swap (400-141f, sliding core uhmpwe, 7mm) which was done at (b)(6) hospital by dr.(b)(6) on a 76 year old female patient.Regional account coordinator, emailed independent sales representative, who was present at the case for details regarding the poly swap.Sage stated that the original implant of the 400-141f was done about 7 years ago.Dr.Saw the patient back for taa follow up and the 400-141f "appeared to be broken on x-ray due to metal wire being split in half.Wire disengaged from the poly, was broken, but the sliding core appeared to be intact with minimal wear".The explanted 400-141 was discarded by the facility however, sage provided a picture of the 400-141f.There were 4 similar complaints identified for star poly component breaking.Previous complaint 22-11-001 was investigated and documented by stryker, so the root cause remains unknown.Additionally, the root cause for similar complaint (b)(4) remains unknown.Thus, the previous complaints do not aid in the investigation for this complaint, ccr 23-10-002.Dhr review was not conducted due to the complaint part not being returned and the lot number remaining unknown.The broken poly was not returned to the houston site, so visual and dimensional inspection did not occur.The reporter provided a photo of the broken poly, and it was confirmed to be damaged.The two x-ray wires are confirmed damaged and outside of the poly the reporter stated "poly appeared to be broken on x ray due to metal wire being split in half.Wire was disengaged from the poly, was broken, but the sliding core appeared to be intact with minimal wear".Simulated use testing did not occur.Per r&d engineer coo, "during sbi's initial wear testing they had some instances of wire fracture or push out (per the test report) this type of breakage in the wire is expected to occur on the bench because the cycling of the polyethylene under high loads causes it to flatten slightly and expand outwardly, exerting circumferential pressure on the wire that leads to breakage.These extreme conditions would not be expected to occur in vivo.Moreover, even under such conditions, the wire protruded from the polyethylene but did not dislodge.This situation is not expected to present a clinical risk in vivo, and in fact, was not observed during the clinical trial." the sbi test report is consistent with the explanted poly.The poly is intact, with slight damage to one of the corners.The wire is broken in half.Based on the information provided and the sbi test report, the root cause shall be attributed to wear and tear - other.

Event Description

On 10/03/2023, customer care representative, emailed a delivered goods form for a star total ankle revision surgery to fa complaints inbox.The star total ankle revision case was a poly swap (400-141f, sliding core uhmpwe, 7mm) which was done at (b)(6) hospital by dr.(b)(6) on a 76 year old female patient.Regional account coordinator, emailed independent sales representative, who was present at the case for details regarding the poly swap.Sage stated that the original implant of the 400-141f was done about 7 years ago.Dr.Saw the patient back for taa follow up and the 400-141f "appeared to be broken on x-ray due to metal wire being split in half.Wire disengaged from the poly, was broken, but the sliding core appeared to be intact with minimal wear".The explanted 400-141 was discarded by the facility however, sage provided a picture of the 400-141f.

• Brand Name: SLIDING CORE, UHMPWE, 7MM
• 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: 18655379
• MDR Text Key: 334722202
• Report Number: 1644408-2024-00209
• 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
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 400-141F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• 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: 76 YR
• Patient Sex: Female