SOLUTION SYSTEMRecalls & reported problems across all models
Depuy Orthopaedics, Inc. · 64 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 258
- Deaths reported
- 0
- Injuries reported
- 203
- Recalls
- 0
We found 64 models of SOLUTION SYSTEM by Depuy Orthopaedics, Inc. in the FDA's device registry (GUDID). Together they are named in 258 adverse event reports in the FDA's MAUDE database, received between Jan 10, 2017 and Jun 12, 2026 — classified as 203 injuries, 55 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (45 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported SOLUTION SYSTEM problems
Device problems
- Adverse Event Without Identified Device or Use Problem67
- Loss of Osseointegration45
- Break39
- Osseointegration Problem37
- Fracture33
- Appropriate Device Problem Term/Code Not Available13
- Failure to Cut13
- Loose or Intermittent Connection7
Patient problems
- No Code Available90
- Pain83
- Inadequate Osseointegration79
- Unspecified Infection44
- Discomfort36
- No Clinical Signs, Symptoms or Conditions34
- Tissue Damage28
- Inflammation23
SOLUTION SYSTEM models
64 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SOLUTION SYSTEM 1257-50-000Prosthesis, hip, semi-constrained, metal/polymer, cemented28 reports
- SOLUTION SYSTEM 1257-40-000Prosthesis, hip, semi-constrained, metal/polymer, cemented26 reports
- SOLUTION SYSTEM 2108-04-000BIT, DRILL24 reports
- SOLUTION SYSTEM 1257-45-000Prosthesis, hip, semi-constrained, metal/polymer, cemented17 reports
- SOLUTION SYSTEM 1257-55-000Prosthesis, hip, semi-constrained, metal/polymer, cemented14 reports
- SOLUTION SYSTEM 1257-25-000Prosthesis, hip, semi-constrained, metal/polymer, cemented13 reports
- SOLUTION SYSTEM 2108-06-000BIT, DRILL10 reports
- SOLUTION SYSTEM 1257-60-000Prosthesis, hip, semi-constrained, metal/polymer, cemented8 reports
- SOLUTION SYSTEM 1257-30-000Prosthesis, hip, semi-constrained, metal/polymer, cemented7 reports
- SOLUTION SYSTEM 1571-53-000PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED5 reports
- SOLUTION SYSTEM 1257-35-000Prosthesis, hip, semi-constrained, metal/polymer, cemented4 reports
- SOLUTION SYSTEM 1257-65-000Prosthesis, hip, semi-constrained, metal/polymer, cemented4 reports
- SOLUTION SYSTEM 1571-84-000PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- SOLUTION SYSTEM 1572-01-136PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- SOLUTION SYSTEM 1572-02-136PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- SOLUTION SYSTEM 1572-02-180PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- SOLUTION SYSTEM 1572-11-136PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- SOLUTION SYSTEM 1571-52-000PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- SOLUTION SYSTEM 1572-01-106PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- SOLUTION SYSTEM 1572-01-165PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- SOLUTION SYSTEM 1572-01-180PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- SOLUTION SYSTEM 1572-02-121PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- SOLUTION SYSTEM 1571-13-000PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- SOLUTION SYSTEM 1571-15-000PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- SOLUTION SYSTEM 1571-43-000PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- SOLUTION SYSTEM 1571-46-000PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- SOLUTION SYSTEM 1572-01-121PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- SOLUTION SYSTEM 1572-01-150PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- SOLUTION SYSTEM 1572-02-106PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- SOLUTION SYSTEM 1572-02-150PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- SOLUTION SYSTEM 1572-08-136PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- SOLUTION SYSTEM 1572-08-150PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- SOLUTION SYSTEM 1572-10-136PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- SOLUTION SYSTEM 1572-10-150PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- SOLUTION SYSTEM 1572-11-165PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 reports
- 2 reports
- 2 reports
- 2 reports
- 2 reports
- 2 reports
- 2 reports
- 2 reports
- 2 reports
- SOLUTION SYSTEM 1571-12-000PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- SOLUTION SYSTEM 1571-14-000PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- SOLUTION SYSTEM 1571-16-000PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- SOLUTION SYSTEM 1571-24-000PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- SOLUTION SYSTEM 1571-27-000PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- SOLUTION SYSTEM 1571-28-000PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- SOLUTION SYSTEM 1571-42-000PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- SOLUTION SYSTEM 1571-44-000PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- SOLUTION SYSTEM 1571-54-000PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- SOLUTION SYSTEM 1571-61-000PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- SOLUTION SYSTEM 1571-74-000PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- SOLUTION SYSTEM 1571-76-000PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- SOLUTION SYSTEM 1571-79-000PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- SOLUTION SYSTEM 1572-02-195PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- SOLUTION SYSTEM 1572-07-136PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- SOLUTION SYSTEM 1572-11-150PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- SOLUTION SYSTEM 1572-11-180PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- SOLUTION SYSTEM 1573-03-000PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- SOLUTION SYSTEM 1573-13-000PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- SOLUTION SYSTEM 2108-08-000BIT, DRILL1 report
- 1 report
Recent SOLUTION SYSTEM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2026Break
IT WAS REPORTED THAT THE ITEM BROKE WHILE INSIDE A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25485417 ↗MalfunctionMay 21, 2026Break; Entrapment of Device
TWO REAMER TIPS FROM THE FEMORAL REV ALLOGRAFT BROKE OFF IN THE PATIENT¿S FEMUR. ONE WAS RETRIEVED. HEALTHCARE PROFESSIONAL ORDER XRAY TO CONFIRM PLACEMENT OF THE SECOND ONE AND WAS UNABLE TO RETRIEVE THE REAMER TIP FROM THE PATIENT¿S FEMUR. THE PROCEDURE WAS CONTINUED AND THE FEMORAL STEM IMPLANTED TO COMPLETE THE PROCEDURE AS INTENDED.
Patient problems: Foreign Body In Patient
MAUDE report 25241378 ↗MalfunctionMay 21, 2026Break
TWO REAMER TIPS FROM THE FEMORAL REV ALLOGRAFT BROKE OFF IN THE PATIENT¿S FEMUR. ONE WAS RETRIEVED. HEALTHCARE PROFESSIONAL ORDER XRAY TO CONFIRM PLACEMENT OF THE SECOND ONE AND WAS UNABLE TO RETRIEVE THE REAMER TIP FROM THE PATIENT¿S FEMUR. THE PROCEDURE WAS CONTINUED AND THE FEMORAL STEM IMPLANTED TO COMPLETE THE PROCEDURE AS INTENDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25241367 ↗MalfunctionApr 6, 2026Break
IT WAS REPORTED THAT 6 MM SOLUTION REAMER BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24791627 ↗MalfunctionFeb 25, 2026Break
IT WAS REPORTED THAT DRILL BIT BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24445834 ↗InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE PRELIMINARY DATA REPORT WAS FROM THE ORTHOPEDIC RESEARCH FOUNDATION (ORTHOINDY), WHICH INCLUDES INFORMATION COLLECTED FROM (B)(6) HOSPITAL AND HEALTH CARE CENTER, AS PART OF AN ON-GOING DATA USE AGREEMENT. THIS IS THE INTERIM VERSION OF THE DATA COLLECTION TEMPLATE (DCT), WHICH INCLUDES SAFETY-RELATED INFORMATION FOR THE VA-LCP PPFX SYSTEM. DURING THE REVIEW, DEPUY SYNTHES JOINT RECONSTRUCTION PRODUCTS WERE IDENTIFIED AS INVOLVED IN SOME OF THE COMPLICATIONS. A TOTAL OF 4 COMPLICATIONS INVOLVING JOINT RECONSTRUCTION PRODUCTS HAVE BEEN REPORTED ACROSS 3 PATIENTS. ALL COMPLICATIONS REQUIRED SURGICAL INTERVENTION. SUBJECT NUMBER (B)(6), 70-YEAR-OLD MALE. PATIENT EXPERIENCED A POST OPERATIVE SUPERFICIAL WOUND INFECTION REQUIRING ANTIBIOTICS AND WOUND VAC. DATE OF ORIGINAL SURGERY WAS ON (B)(6) 2024.
Patient problems: Fluid Discharge; Post Operative Wound Infection
MAUDE report 23526192 ↗MalfunctionAug 5, 2025Break; Break
IT WAS REPORTED THAT DRILL BIT BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22720034 ↗MalfunctionJul 1, 2025Break; Break
IT WAS REPORTED THAT THE SOL SYS CEM PLUG DRILLS 6.0MM WAS BROKEN AND RETRIEVED. SOL SYS CEM PLUG DRILLS 4.5MM WAS BROKEN AND NOT RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22374636 ↗MalfunctionJul 1, 2025Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT THE SOL SYS CEM PLUG DRILLS 6.0MM WAS BROKEN AND RETRIEVED. SOL SYS CEM PLUG DRILLS 4.5MM WAS BROKEN AND NOT RETRIEVED.
Patient problems: Foreign Body In Patient
MAUDE report 22374013 ↗MalfunctionJan 28, 2025Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT THE DRILL BIT BROKE INSIDE PATIENT.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 21256465 ↗MalfunctionAug 21, 2024Break; Break
IT WAS REPORTED THAT THE DRILL BIT BROKE IN FEMUR TRYING TO REMOVE CEMENT.
Patient problems: Insufficient Information
MAUDE report 20017895 ↗InjuryAug 20, 2024Osseointegration Problem; Osseointegration Problem
THE PATIENT'S PINNACLE REVISION CUP AND CONSTRAINED LINER PARTIALLY PULLED OUT OF THE ACETABULUM. THE SURGEON REMOVED THE CONSTRAINED LINER, ACETABULAR CUP AND FIVE SCREWS. A NEW REVISION CUP AND DUAL MOBILITY LINER WERE PLACED.
Patient problems: Inadequate Osseointegration
MAUDE report 20002007 ↗InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO INFECTED RIGHT THA. REMOVED THE CONSTRAINED LINER, TWO 5.0 PERIPHERAL SCREWS. REPLACED WITH A NEW CONSTRAINED LINER. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 19994179 ↗InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO INFECTED RIGHT THA. REMOVED THE CONSTRAINED LINER, TWO 5.0 PERIPHERAL SCREWS. REPLACED WITH A NEW CONSTRAINED LINER. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 19973786 ↗InjuryJun 27, 2024Fracture; Fracture
ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO SURGICAL DELAY AND NO ALLEGATION AGAINST THE HEAD.
Patient problems: Insufficient Information
MAUDE report 19624938 ↗
Other Depuy Orthopaedics, Inc. products
- PINNACLE ALTRX98 models · 5,631 reports
- BIOLOX DELTA40 models · 4,995 reports · 1 recall
- PINNACLE182 models · 4,587 reports
- QUICKSET7 models · 3,790 reports
- PINNACLE POROCOAT38 models · 2,112 reports
- SUMMIT POROCOAT20 models · 1,646 reports
- PINNACLE GRIPTION57 models · 1,608 reports
- DURALOC93 models · 1,262 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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