SOLARRecalls & reported problems across all models
Howmedica Osteonics Corp. · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one SOLAR model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 2
We found 13 models of SOLAR by Howmedica Osteonics Corp. in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Jan 9, 2019 and Oct 1, 2024 — classified as 4 injuries.
The most frequently reported specific device problem is “Degraded” (1 report).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
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
SOLAR recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 30, 2026Open, Classified
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.
Z-3200-2026 · Root cause: Process change control · names 8 of these models · Recall details · FDA record ↗
- Jul 30, 2026Open, Classified
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.
Z-3199-2026 · Root cause: Process change control · Recall details · FDA record ↗
Most reported SOLAR problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Degraded1
- Device Dislodged or Dislocated1
- Insufficient Device Problem Information1
- Migration1
- Osseointegration Problem1
Patient problems
- Insufficient Information2
- Inadequate Osseointegration1
- Injury1
- Loss of Range of Motion1
SOLAR models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SOLAR 5361-6109PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall0 reports
- SOLAR 5361-6205PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall0 reports
- SOLAR 5361-6111PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall0 reports
- SOLAR 5361-6107PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall0 reports
- SOLAR 5361-6105PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall0 reports
- SOLAR 5361-6209PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall0 reports
- SOLAR 5361-6207PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall0 reports
- SOLAR 5361-6211PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall0 reports
- SOLAR C-M110-1-201PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall0 reports
- SOLAR 5005-102LPROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 report
- SOLAR 5005-013RPROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 report
- SOLAR 5352-5018PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
- SOLAR 5005-3040PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
Recent SOLAR adverse event reports
The 4 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUFF FAILURE OF HEMI. REVISION OF STRYKER SOLAR TSA HEMI TO RSA.
Patient problems: Insufficient Information
MAUDE report 20348157 ↗InjuryNov 17, 2022Degraded; Migration; Degraded; Migration
CURRENT ULNA IMPLANT HAS ERODED THROUGH THE BONE CAUSE FAILURE AND LITTLE TO NO RANGE OF MOTION FOR THE PATIENT.
Patient problems: Loss of Range of Motion
MAUDE report 15812792 ↗InjuryMay 20, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
IT HAS BEEN REPORTED "FREQUENT AXLE AND POLY FAILURES. IT HAS BEEN EVERY 3RD YEAR SINCE 2015."
Patient problems: Insufficient Information
MAUDE report 14463937 ↗InjuryJan 9, 2019Device Dislodged or Dislocated; Osseointegration Problem; Device Dislodged or Dislocated; Osseointegration Problem
REVISION OF ULNAR COMPONENT FOR ASEPTIC LOOSENING.
Patient problems: Inadequate Osseointegration; Injury
MAUDE report 8232520 ↗
Other Howmedica Osteonics Corp. products
- Triathlon608 models · 3,524 reports · 15 recalls
- Scorpio107 models · 113 reports · 28 recalls
- Trident160 models · 1,280 reports · 2 recalls
- Accolade57 models · 1,228 reports
- Duracon58 models · 65 reports · 16 recalls
- LFIT23 models · 852 reports
- TRIDENT II42 models · 188 reports · 12 recalls
- INSTRUMENT131 models · 290 reports · 7 recalls
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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