NA 2531-08-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295129080), received between Mar 30, 2020 and Sep 27, 2024 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (12 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2024Scratched Material; Scratched Material

  IT WAS REPORTED ON AUGUST 20, 2024 THAT ALL ITEMS ARE SCRATCHED DUE TO REPEATED USE. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20325851 ↗
• MalfunctionJan 3, 2024Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  COMPLAINT IS RELATED TO (B)(4). THIS COMPLAINT WAS CREATED DUE TO THE EXCESS IMPACTED PRODUCTS IN (B)(4). DAMAGED PLASTIC FEMORAL HEAD TRIALS NEED REPLACEMENT. PLASTIC IS WORN AND SCRATCHED ON HEAD TRIALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18434849 ↗
• MalfunctionJan 3, 2024Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  COMPLAINT IS RELATED TO (B)(4). THIS COMPLAINT WAS CREATED DUE TO THE EXCESS IMPACTED PRODUCTS IN (B)(4). DAMAGED PLASTIC FEMORAL HEAD TRIALS - NEED REPLACEMENT PLASTIC IS WORN AND SCRATCHED ON HEAD TRIALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18434848 ↗
• MalfunctionJan 3, 2024Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  COMPLAINT IS RELATED TO (B)(4). THIS COMPLAINT WAS CREATED DUE TO THE EXCESS IMPACTED PRODUCTS IN (B)(4). DAMAGED PLASTIC FEMORAL HEAD TRIALS - NEED REPLACEMENT. PLASTIC IS WORN AND SCRATCHED ON HEAD TRIALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18434846 ↗
• MalfunctionNov 28, 2023Break; Naturally Worn; Scratched Material; Break; Naturally Worn; Scratched Material

  ADDITIONAL CASE IN REGARDS TO (B)(4) AS IT HAS MORE THAT 10 IMPACTED PRODUCTS. PLASTIC TRIALS ARE WORN OUT, WITH DAMAGE TO THE PLASTIC. POSSIBLE PLASTIC SHARDS. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18215809 ↗
• MalfunctionNov 21, 2023Break; Naturally Worn; Scratched Material; Break; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE FEMORAL TRIAL HEAD HAS DAMAGED PLASTIC POSSIBLY SHEDDING PLASTIC SHARDS. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18180835 ↗
• MalfunctionNov 21, 2023Break; Naturally Worn; Scratched Material; Break; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE FEMORAL TRIAL HEAD HAS DAMAGED PLASTIC POSSIBLY SHEDDING PLASTIC SHARDS. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18180831 ↗
• MalfunctionFeb 8, 2023Peeled/Delaminated; Naturally Worn; Peeled/Delaminated; Naturally Worn

  IT WAS REPORTED THAT THE TRIAL HEADS WERE WORN TO THE POINT THE PLASTIC WAS FLAKING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16329166 ↗
• MalfunctionFeb 8, 2023Peeled/Delaminated; Naturally Worn; Peeled/Delaminated; Naturally Worn

  IT WAS REPORTED THAT THE TRIAL HEADS WERE WORN TO THE POINT THE PLASTIC WAS FLAKING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16325467 ↗
• MalfunctionOct 21, 2020Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT THE HEADS ARE IN A BAD SHAPE. PLASTIC IS CUT FROM RETRACTS AND INSTRUMENTS. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10711278 ↗
• MalfunctionOct 21, 2020Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT THE HEADS ARE IN A BAD SHAPE. PLASTIC IS CUT FROM RETRACTS AND INSTRUMENTS. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10711277 ↗
• MalfunctionOct 21, 2020Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT THE HEADS ARE IN A BAD SHAPE. PLASTIC IS CUT FROM RETRACTS AND INSTRUMENTS. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10711276 ↗
• MalfunctionOct 21, 2020Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT THE HEADS ARE IN A BAD SHAPE. PLASTIC IS CUT FROM RETRACTS AND INSTRUMENTS. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10711275 ↗
• MalfunctionMar 30, 2020Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE 32 + 40MM HEAD TRIALS NEED REPLACED DUE TO SCRATCHES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9901026 ↗
• MalfunctionMar 30, 2020Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE 32 + 40MM HEAD TRIALS NEED REPLACED DUE TO SCRATCHES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9900989 ↗