NA 2531-06-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295129066), received between Dec 11, 2017 and May 21, 2026 — classified as 20 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• 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 25241677 ↗
• 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 25241291 ↗
• MalfunctionJan 3, 2024Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  ADDITIONAL INFORMATION RECEIVED: A. WHAT WAS SPECIFICALLY THE DAMAGE ON THE DEVICES (BROKEN (2+ PIECES), CRACKED, BENT, STRIPPED/WORN). PLASTIC IS WORN AND SCRATCHED ON HEAD TRIALS. B. CAN YOU PLEASE PROVIDE THE LOT NO OF THE REPORTED PRODUCTS? WORKING WITH OPS TO SWAP OUT, LOT NUMBERS WILL. BE AVAILABLE ON RETURN OF TRIAL HEADS C. WHAT IS THE EVENT DATE? AS REPORTED BY THE PC- HEADS HAVE BEEN WORN OVER TIME WITH USE. D. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO. E. DID THE EVENT OCCUR DURING THE SURGERY? IF YES, WAS THERE A SURGICAL DELAY? WHAT IS THE DURATION OF THE DELAY? NO, IDENTIFIED OUTSIDE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18434839 ↗
• 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 18434836 ↗
• 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 18236073 ↗
• 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 18180878 ↗
• 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 18180870 ↗
• 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 18180863 ↗
• 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 16325535 ↗
• 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 16325437 ↗
• 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 11783891 ↗
• 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 10711292 ↗
• 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 10711287 ↗
• 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 10704986 ↗
• 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 10704983 ↗
• MalfunctionMay 8, 2020Material Integrity Problem; Scratched Material; Material Integrity Problem; Scratched Material

  IT WAS REPORTED THAT THE INSTRUMENTS FOUND DEFECTS WHEN RETURNED TO THE OFFICE FOR INSPECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10039749 ↗
• 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 9901018 ↗
• 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 9900995 ↗
• MalfunctionNov 16, 2018Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE 40MM + 5 HIP BALL WAS HANDED TO SALES REP SINCE THERE WAS A LARGE SCRATCH IN THE TRIAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8080299 ↗
• MalfunctionDec 11, 2017Break; Break

  IT WAS REPORTED THAT THE 40+5 TRIAL HIP BALL WAS BROKEN BY THE SURGEON. SURGICAL DELAY OF 3 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7104647 ↗