NA 2531-07-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295129073), received between Mar 30, 2020 and Jun 20, 2025 — classified as 16 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22302254 ↗
• 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 18434844 ↗
• 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 18434841 ↗
• 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 18434838 ↗
• 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 18180867 ↗
• 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 18180850 ↗
• 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 18180840 ↗
• 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 16325573 ↗
• 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 16325557 ↗
• MalfunctionMay 6, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WORN INSTRUMENTS IDENTIFIED BY SPD AS NEEDING TO BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11783870 ↗
• 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 10711285 ↗
• MalfunctionOct 21, 2020Crack; Naturally Worn; Crack; Naturally Worn

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10711284 ↗
• 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 10711283 ↗
• 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 10711282 ↗
• MalfunctionMar 30, 2020Scratched Material; Scratched Material

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9901012 ↗
• MalfunctionMar 30, 2020Scratched Material; Scratched Material

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9901007 ↗