TRANSCEND® 26000017Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M684260000171), received between Jun 26, 2019 and Jun 1, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Disintegration” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 1, 2023Noise, Audible; Noise, Audible

  ALLEGEDLY, THE PATIENT HAD A REVISION SURGERY 2 DAYS BEFORE. THE PATIENT IS COMPLAINING OF CLICKING OF THE RIGHT HIP. IT WAS FELT SHE MAY HAVE SOME METAL IMPINGING IN THE HIP AND IT WAS FELT SHE WOULD BENEFIT FROM REVISION IN ORDER TO DECREASE THE CLICKING, DECREASE RISK OF DISLOCATION AND INCREASE THE LONGEVITY OF THE PROSTHESIS. OPERATIVE FINDINGS: WHEN THE HIP WAS EXTENDED AND EXTERNALLY ROTATED, THE METAL BODY OF THE PROFERNUR R DID STRIKE THE POSTERIOR RIM OF THE SHELL. IT MADE A CLICKING NOISE BUT DID NOT DISLOCATE THE BALL BECAUSE OF LARGE DISTANCE. DECREASED OFFSET WITH METAL BODY IMPINGING ON THE METAL SHELL. NON REVISED PRODUCTS: PRODUCT ID: SPHS8000 PROFEMUR® R 135MM.STEM SIZE 10 MTS.FINISH STRAIGHT/TAPER/ LOT NO.: 07493194/ QTY: 1. NON MPO PRODUCTS: STRYKER MDM 58-MRN, 58 / 46 METAL LINER, 46-MRN POLY BALL, 30-MRN ACETABULAR SCREWS & 35-MRN ACETABULAR SCREWS.

  Patient problems: Loss of Range of Motion

  MAUDE report 17043482 ↗
• InjuryAug 4, 2020Material Disintegration; Material Disintegration

  ALLEGEDLY , THE SUSPICION OF ADVERSE REACTION TO METAL DEBRIS MAY BE ESPECIALLY BETWEEN NECK AND HEAD. DR. WANTS TO INVESTIGATE THE EXISTENCE OF ADVERSE REACTION TO METAL DEBRIS AS FOLLOWING. USED OUR PROFEMURXM, CHANGEABLE NECK, METAL HEAD ONLY AND USED DEPUY PINA CUP AND MARASON LINER 28MM DIAMETER FLAT. A FEW DAYS AGO, THE PATIENT COMPLAINED OF ABNORMAL NOISE FROM HIS JOINT SPINNING PREVENTION TAB OF 6 PIN CUP MARATHON LINER 4 OUT OF 6 DAMAGED. REPLACE WITH MARATHON LINER 32MM FLAT. OUR STEAM IS ALSO REPLACED WITH A CHANGEABLE NECK AR8 LONG AND A DELTA HEAD 32 MM LONG. (B)(6).

  Patient problems: Reaction

  MAUDE report 10361494 ↗
• InjuryFeb 7, 2020Difficult to Insert; Fitting Problem; Difficult to Insert; Fitting Problem

  ALLEGEDLY, SHELL DID NOT ATTACH TO THE BALL. ADDITIONAL INFORMATION ON 01/31/2020: REPORTER STATED THAT DURING SURGERY THE HEAD DID NOT ATTACH TO THE SHELL. THEY WERE USING A 28 HEAD AND A 45 BIPOLAR SHELL. ACCORDING TO THE REPORTER, HE NOTICED THAT THE PLASTIC RIM INSIDE THE SHELL DID NOT SEEM FLUSH TO THE SHELL (THERE WAS A 3-4MM GAP) AND HE THINKS THAT IT MAY BE THE REASON WHY THE HEAD DID NOT ATTACH TO THE SHELL. IN THE END, THEY USED A 32 HEAD AND A 46 SHELL. THESE FUNCTIONED WELL.

  Patient problems: No Information

  MAUDE report 9682793 ↗
• InjuryJun 26, 2019Material Disintegration; Material Disintegration

  ALLEGEDLY THE PATIENT WAS REVISED DUE TO MOM COMPLICATIONS: METALLOSIS.

  Patient problems: Reaction

  MAUDE report 8736890 ↗