LCS COMPLETE 1294-27-070Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295025405), received between Mar 28, 2018 and Mar 28, 2018 — 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION TOTAL KNEE REPLACEMENT (B)(6) PRIVATE HOSPITAL (B)(6) 2018. PATIENT UNDERWENT PRIMARY TOTAL KNEE REPLACEMENT IN 2015 (DR (B)(6)), WHERE AN LCS TKR WAS UTILISED (CAT NUMBER AND DATE/ PLACE TO FOLLOW WHEN AVAILABLE). THE 1ST REVISION, PATIENT HAD STIFFNESS AND PAIN, PATIENT UNDERWENT A REVISION TKR IN 2016 (DR (B)(6)), AND THEN 2ND REVISION ADDITIONAL SURGERY IN 2017 WHERE THE PATELLA COMPONENT WAS REVISED (DR (B)(6)). PATIENT HAS NOW PRESENTED WITH STIFFNESS, PAIN AND INSTABILITY. PATIENT STRUGGLES ON STAIR ACCENT AND DECENT. NIGHT PAINS, ESPECIALLY SEVERE WHEN ROLLING OVER. A DECISION WAS MADE TO REVISE THE KNEE (DR (B)(6), (B)(6) HOSPITAL 5/03/18) ON OPENING THE KNEE THE KNEE WAS TIGHT IN FLEXION AND LOOSE FROM 10 DEGREES FLEXION TO APPROXIMATELY 45 DEGREES OF FLEXION, WITH KNEE GAPPING UP TO 7-10MM. THE KNEE WAS REVISED TO A TC 3 RP. MALE PATIENT (B)(6). UNKNOWN_JRN: LCS LARGE FEM, UNKNOWN_JRN: SIZE 5 MTB TRAY, UNKNOWN_JRN: 2 X UNIVERSAL STEMS, UNKNOWN_JRN: LCS BEARING LARGE 10MM.

  Patient problems: Pain

  MAUDE report 7376797 ↗
• InjuryMar 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION TOTAL KNEE REPLACEMENT (B)(6) HOSPITAL (B)(6) 2018. PATIENT UNDERWENT PRIMARY TOTAL KNEE REPLACEMENT IN 2015 (DR (B)(6)), WHERE AN LCS TKR WAS UTILISED (CAT NUMBER AND DATE/ PLACE TO FOLLOW WHEN AVAILABLE). THE 1ST REVISION, PATIENT HAD STIFFNESS AND PAIN, PATIENT UNDERWENT A REVISION TKR IN 2016 (DR (B)(6)), AND THEN 2ND REVISION ADDITIONAL SURGERY IN 2017 WHERE THE PATELLA COMPONENT WAS REVISED (DR (B)(6)). PATIENT HAS NOW PRESENTED WITH STIFFNESS, PAIN AND INSTABILITY. PATIENT STRUGGLES ON STAIR ACCENT AND DECENT. NIGHT PAINS, ESPECIALLY SEVERE WHEN ROLLING OVER. A DECISION WAS MADE TO REVISE THE KNEE (DR (B)(6), (B)(6) 2018). ON OPENING THE KNEE THE KNEE WAS TIGHT IN FLEXION AND LOOSE FROM 10 DEGREES FLEXION TO APPROXIMATELY 45 DEGREES OF FLEXION, WITH KNEE GAPPING UP TO 7-10MM. THE KNEE WAS REVISED TO A TC 3 RP. MALE PATIENT (B)(6). UNKNOWN_JRN: LCS LARGE FEM, UNKNOWN_JRN: SIZE 5 MTB TRAY, UNKNOWN_JRN: 2 X UNIVERSAL STEMS, UNKNOWN_JRN: LCS BEARING LARGE 10MM.

  Patient problems: Pain

  MAUDE report 7376794 ↗