Centrax 6226-2-645Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327032192), received between Feb 27, 2017 and Apr 7, 2021 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2021Naturally Worn; Naturally Worn

  ON (B)(6) 2015 THE FIRST THA PROCEDURE WAS PERFORMED. THE PATIENT COMPLAINED OF PAIN FROM AROUND (B)(6) 2021. ON (B)(6) 2021 REVISION WAS PERFORMED FOR SUSPICION OF METALLOSIS DUE TO WEAR OF POLYETHYLENE FROM CENTRAX. PLEASE INVESTIGATE THE DEGREE OF POLYETHYLENE WEAR.

  Patient problems: Inflammation; Pain

  MAUDE report 11632148 ↗
• InjuryFeb 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ABOUT A PATIENT REGISTERED FOR JOIN RESEARCH. THE STUDY WAS DISCONTINUED DUE TO WORSENING GENERAL CONDITION TRIGGERED BY JAUNDICE AND ACUTE CHOLECYSTITIS.

  Patient problems: Insufficient Information; Jaundice

  MAUDE report 11348322 ↗
• MalfunctionMar 25, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A BHA, AFTER THE LOCKING, A SURGEON NOTICED A GAP BETWEEN THE SHELL AND LOCKING RING. HE USED A SPARE CENTRAX INSTEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9879132 ↗
• InjuryJan 9, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  INITIAL PROCEDURE WAS (B)(6) 2017 FOR LEFT. (B)(6) 2017, THE PATIENT WAS DISLOCATED, BUT IT 'S UNKNOWN WHICH SIDE IS DISLOCATED. REDUCED AND RECOVERED THE NEXT DAY.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9569222 ↗
• InjuryMay 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE EXPLANTING OF BIPOLAR WAS PERFORMED DUE TO THE SUSPICION OF METAL ALLERGY. A LARGE AMOUNT OF LUMPY TISSUE EMERGED FROM THE HIP OF THE PATIENT. THE CUSTOMER WOULD LIKE TO KNOW THE AMOUNT OF POLYETHYLENE WEAR. EVENT UPDATE PER REVIEW OF THE CLINICIAN'S COMMENT: REJECTED FOR MEDICAL REVIEW - SPACER NOTED ON X-RAY INDICATES INFECTION, HOWEVER, CANNOT CONFIRM INFECTION OR REPORTED EVENT.

  Patient problems: Injury; Reaction

  MAUDE report 8592064 ↗
• InjuryDec 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AT (B)(6) 2015, BIPOLAR HIP ARTHROPLASTY WAS DONE. THE PATIENT HAD THE CONTINUOUS THIGH PAIN AFTER SURGERY. LOOSENING AND INFECTION WAS NOT CONFIRMED. THE REVISION SURGERY WAS NOT PLANED. THE SURGEON WANT TO KNOW THE POSSIBLE REASON.

  Patient problems: Pain

  MAUDE report 8204796 ↗
• MalfunctionOct 12, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT, DURING A BHA, THE V40 COULD NOT SLIDE SMOOTHLY IN THE CENTRAX. THEY WERE IMPLANTED AS IS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6946050 ↗
• MalfunctionSep 6, 2017Device Operates Differently Than Expected; Scratched Material; Device Operates Differently Than Expected; Scratched Material

  THE MOVEMENT OF THE HEAD WAS TOO BAD. SO USED ANOTHER PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6846444 ↗
• MalfunctionJun 26, 2017Device Operates Differently Than Expected; Device Slipped; Device Operates Differently Than Expected

  WHEN A DOCTOR SET FEMORAL HEAD INTO BIPOLAR CUP, HE FOUND THE MOVEMENT OF THE FEMORAL HEAD IN BIPOLAR WAS NOT SMOOTH. IT SEEMED TO BE TIGHTER THAN USUAL.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 6668853 ↗
• MalfunctionApr 10, 2017Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT, DURING A SURGERY, THE SURGEON FELT THAT THE CENTRAX DID NOT MOVE SMOOTHLY ON THE HEAD. IT WAS IMPLANTED AS IS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6477648 ↗
• MalfunctionFeb 27, 2017Device Operates Differently Than Expected; Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A BHA, THE SURGEON ASSEMBLED THE CENTRAX AND V40 HEAD. THE HEAD DID NOT SLIDE SMOOTHLY ON THE SLIDING SURFACE OF THE REPORTED CENTRAX. REGARDING SLIDING MOTION, HE FELT A TIGHT FEELING. HEAD WAS USED AS IS.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6362646 ↗