PROFEMUR® PRTL0028Recalls & reported problems
Microport Orthopedics Inc. · PROFEMUR® TL STEM SZ 8 · Class 2 · Implant
All models of PROFEMUR (116)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M684PRTL00281), received between Jun 18, 2019 and Aug 4, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information2
Patient problems
- Loss of Range of Motion1
- Metal Related Pathology1
- No Information1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 4, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, THE PATIENT HAD A WRIGHT MEDICAL HIP IMPLANTED ON JAN 2011. SHE STATED THAT SHE HAD GONE BACK TO THE DOCTOR OVER THE YEARS AND WAS TOLD SHE HAD NO ISSUES AND RECENTLY FOUND OUT SHE HAD METALLOSIS. ADDITIONAL INFORMATION RECEIVED ON 2023-07-11. THE PATIENT IS ALLEGING PAIN, CAN?T WALK, ELEVATED BLOOD COBALT THAT IS AFFECTING HER OTHER ORGANS. AS OF THIS DATE SHE HAS NOT BEEN REVISED.
Patient problems: Loss of Range of Motion; Metal Related Pathology; Pain
MAUDE report 17461148 ↗InjuryJun 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT REVISED DUE TO UNKNOWN COMPLICATIONS.
Patient problems: No Information
MAUDE report 8708379 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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