SOLUTION SYSTEM 1571-52-000Recalls & reported problems

Depuy Orthopaedics, Inc. · SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER HIP STEM W/ POROCOAT 8 Inches 10.5mm MMA · Class 2 · Implant

All models of SOLUTION SYSTEM (64)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 3
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295061052), received between Jul 20, 2017 and Jan 26, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (3 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Fracture3
Osseointegration Problem1

Patient problems

Pain2
Ambulation or Postural Difficulties1
Bone Fracture(s)1
Fall1
Inadequate Osseointegration1
Insufficient Information1
No Information1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

InjuryJan 26, 2024Fracture; Osseointegration Problem; Fracture; Osseointegration Problem
ADDITIONAL INFORMATION RECEIVED: A. COULD YOU CONFIRM THE PRIMARY SURGERY DATE OR THE ORIGINAL IMPLANTATION DATE? DATE OF SURGERY (B)(6) 2010. B. COULD YOU PLEASE PROVIDE THE MEDICAL RECORDS/CLINICAL NOTES BETWEEN 2010 (FIRST REVISION SURGERY) AND 2024 WHEN YOU PRESENTED WITH EXISTING COMPLAINT (BROKEN IMPLANT)? NO MEDICAL ISSUE BETWEEN 2010-2024 RELATED TO HIP SURGERY. ONLY HISTORY OF FALL AT HOME ON (B)(6) 2024 WHILE WALKING IN VERANDA WHICH LEAD TO PROSTHESIS BREAKAGE. C. IS RE -REVISION DONE (TO REMOVE BROKEN IMPLANT)? YES REVISION SURGERY DONE.
Patient problems: Ambulation or Postural Difficulties; Fall; Inadequate Osseointegration; Insufficient Information; Pain
MAUDE report 18586309 ↗
InjuryOct 3, 2018Fracture; Fracture
PATIENT LAWYER IS CLAIMING FOR COMPENSATION: PATIENT RECEIVED SOLUTION STEM RIGHT SIDE ON (B)(6) 2017. PAIN WITHOUT ANY TRAUMA FOR ABOUT THREE WEEKS, THEN REVISION OF STEM ON (B)(6) 2018 AS STEM FRACTURE WAS DIAGNOSED.
Patient problems: Bone Fracture(s); Pain
MAUDE report 7930076 ↗
InjuryJul 20, 2017Fracture; Fracture
IT WAS INDICATED THAT THE SURGEON REPORTED A HIP STEM IS BROKEN. THE PRODUCT IS IMPLANTED IN THE PATIENT.
Patient problems: No Information
MAUDE report 6729194 ↗

Device details

UDI-DI	`10603295061052`
Brand	SOLUTION SYSTEM
Model	1571-52-000
Catalog no.	157152000
Company	Depuy Orthopaedics, Inc.
Product code	LPH · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Class	Class 2
FDA submission	K953703
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 13, 2024

Device type (GMDN): Coated femoral stem prosthesis, one-piece

A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is one-piece, is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices

PINNACLE 1217-25-500
Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
735 reports
NA 1365-52-000
Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
683 reports
APEX 1246-03-000
Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
3 deaths613 reports
PINNACLE 1217-20-500
Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
2 deaths590 reports
PINNACLE 1217-30-500
Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
1 death484 reports
NA 1365-53-000
Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
404 reports
PINNACLE ALTRX 1221-36-054
Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
388 reports
PINNACLE ALTRX 1221-32-050
Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
386 reports

All PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices →

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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