Arthrex® AR-516-7LRecalls & reported problems
Arthrex, Inc. · IBAL TKA FEM IMP PS,CEMENTED SZ 7 LFT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867109384), received between Dec 12, 2019 and Dec 12, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).
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
- Loose or Intermittent Connection1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 12, 2019Loose or Intermittent Connection
IT WAS REPORTED BY THE PATIENT THAT HE HAD TOTAL KNEE RECONSTRUCTION ON (B)(6) 2015. ABOUT TWO YEARS AGO THE PATIENT STARTED EXPERIENCING PAIN IN THE KNEE. PER THE PATIENT, X-RAYS WERE TAKEN AND IT WAS DETERMINED THE KNEE IS NOW LOOSE. PATIENT IS SCHEDULED FOR A REVISION LEFT TKA SURGERY ON (B)(6) 2019. ADDITIONAL INFORMATION OBTAINED 10/10/2019: THE PATIENT HAD UNDERGONE A BI-LATERAL TKA PROCEDURE ON (B)(6) 2015. PATIENT REPORTED THAT BONE SCANS WERE TAKEN WHICH CONFIRMED HIS LEFT TIBIAL IMPLANT TO BE LOOSE. PATIENT STATED HE HAS DEALT WITH THE PAIN AND ACCOMPANYING ISSUES FOR OVER TWO YEARS, TAKING 1000 MG OF TYLENOL AND 800 MG OF IBUPROFEN DAILY OVER PAST SEVERAL YEARS, BUT REPORTS HIS LEG IS NOW BOWED AND CAUSING SCIATICA TYPE PAIN IN HIS HIP. DURING THE (B)(6) 2015 ORIGINAL PROCEDURE THE PATIENT HAD THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED IN HIS LEFT KNEE: AR-503-TTTH, TIBIAL TRAY IMPLANT (LOT 1358298), AR-516-7L, FEMORAL IMPLANT (LOT 1373719), AR-513-BH12, BEARING IMPLANT (LOT 113601409), AR-504-PSD0, PATELLA IMPLANT (LOT 113601430). ADDITIONAL INFORMATION OBTAINED 11/19/2019: CONFIRMATION WAS RECEIVED THAT THE PATIENT'S LEFT TKA REVISION PROCEDURE TOOK PLACE AS SCHEDULE
Patient problems: Pain
MAUDE report 9457412 ↗
Other PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER devices
- Scorpio 73-3910Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls4 reports
- Scorpio 73-3508Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls3 reports
- Arthrex® AR-503-TTTCArthrex, Inc. · PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall15 reports
- Arthrex® AR-503-TTTFArthrex, Inc. · PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- Scorpio 73-3308Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- Arthrex® AR-504-PSC9Arthrex, Inc. · PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER11 reports
- RESTORIS 160405Mako Surgical Corp. · PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER7 reports
- Arthrex® AR-504-PSD0Arthrex, Inc. · PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER7 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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