NA 2531-05-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295129059), received between Mar 30, 2020 and Jul 27, 2026 — classified as 22 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50000713 ↗
• MalfunctionMay 21, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE HEAD TRIALS SLIP OFF NECK TRIALS DURING SURGERY. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241284 ↗
• MalfunctionMay 21, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE HEAD TRIALS SLIP OFF NECK TRIALS DURING SURGERY. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241281 ↗
• MalfunctionAug 26, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED. ¿ PLEASE CONFIRM IF ALL FRAGMENTS RETRIEVED FROM PATIENT? - YES. ¿ WAS THERE ANY PATIENT CONSEQUENCES REPORTED? - NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22897460 ↗
• MalfunctionMay 28, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS A BROKEN INSTRUMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22097094 ↗
• MalfunctionMar 28, 2025Break; Break

  IT WAS REPORTED THAT A SMALL PIECE OF THE GREEN 40 +1.5MM HEAD TRIAL BROKE OFF WHEN TRYING TO REDUCE THE HIP. ALL PIECES WERE RETRIEVED FROM THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES AND THERE WAS NO DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21717852 ↗
• MalfunctionOct 25, 2024Break; Scratched Material; Break; Scratched Material

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE TRIAL HEAD WAS SCRATCHED AND PLASTIC FRAGMENTS WERE COMING OFF. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORTED PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 20532181 ↗
• MalfunctionNov 30, 2023Naturally 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18236078 ↗
• MalfunctionNov 30, 2023Naturally 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18236077 ↗
• MalfunctionNov 30, 2023Naturally 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18236075 ↗
• MalfunctionNov 22, 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 18190833 ↗
• 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 18180877 ↗
• MalfunctionNov 20, 2023Break; Naturally Worn; Scratched Material; Break; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE FEMORAL TRIAL HEAD IS WORN, SCRATCHED AND POSSIBLY SHEDDING PLASTIC SHARDS. PATIENT STATUS/ OUTCOME / CONSEQUENCES NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18177969 ↗
• 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 16325491 ↗
• 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 16325394 ↗
• 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 11783869 ↗
• MalfunctionOct 20, 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 10704990 ↗
• MalfunctionOct 20, 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 10704988 ↗
• MalfunctionOct 20, 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 10704982 ↗
• MalfunctionOct 20, 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 10704981 ↗
• 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 9901038 ↗
• 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 9901011 ↗