SIGMA 1024-04-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295001683), received between Mar 6, 2018 and Jul 14, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 other recall cover devices cleared under the same FDA submission (K061648, K233980); they may or may not involve this specific model.

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

Recent adverse event reports

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

• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT HAD A RIGHT ARTHROSCOPY, INCISION AND DRAINAGE OF THE RIGHT KNEE TO ADDRESS PERSISTENT RIGHT KNEE DRAINAGE STATUS POST ARTHROSCOPY AND LATERAL RELEASE. THE INDICATIONS FOR SURGERY NOTED THAT THE PATIENT HAD RECENTLY HAD AN ARTHROSCOPY LATERAL RELEASE AND REMOVAL OF AN OSTEOPHYTE FOR PERSISTENT PAIN, STATUS POST PATELLOFEMORAL ARTHROPLASTY. THE PATIENT PRESENTED WITH PERSISTENT DRAINAGE AND IT WAS FELT THAT AN I&D WITH CULTURES AND ANTIBIOTIC WAS INDICATED TO PREVENT THE POSSIBILITY OF INFECTING HIS PRE-EXISTING PROTHESIS. NO COMPONENTS REVISED. POST OPERATIVELY, THE 48 HOUR CULTURES WERE NEGATIVE FOR INFECTION. DOI: (B)(6) 2014. DOE: (B)(6) 2017; RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fluid Discharge; Pain

  MAUDE report 12166697 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT HAD AN ARTHROSCOPY WITH LATERAL RELEASE, MEDICAL MENISCECTOMY, EXCISION BONE SPUR/OSTEOPHYTE PATELLA, EXCISION, MEDIAL AND LATERAL PLICA, AND CHONDROPLASTY, MEDICAL FEMORAL CONDYLE, RIGHT KNEE TO ADDRESS BONE SPUR/OSTEOPHYTE PATELLA, STATUS POST PATELLOFEMORAL ARTHROPLASTY, TEAR OF MEDIAL MENISCUS, CHONDROSIS, MEDIAL FEMORAL CONDYLE, AND MEDIAL AND LATERAL PLICA, RIGHT KNEE. THE INDICATIONS FOR SURGERY INCLUDED INCREASING PAIN. PREOPERATIVE RADIOGRAPHS WERE NOTED TO SHOW THAT THE PATIENT HAD AN OSTEOPHYTE THAT APPEARED TO BE OVERHANGING AT THE LATERAL BORDER OF HIS PATELLA. THE PATIENT ALSO HAD SLIGHTLY TIGHT AT THE LATERAL SIDE AND THE RETINACULAR RELEASE MAY BE NEEDED. THE PATELLA WAS NOTED TO REVEAL NO WEAR AND TEAR. DURING THE PROCEDURE THE OBSERVED A SMALL TEAR AT THE MEDIAL MENISCUS THAT WAS CATCHING ON A GRADE III CHONDRAL LESION. THE PATIENT HAD NORMAL POSITION OF HIS PATELLOFEMORAL ARTHROPLASTY. THE OSTEOPHYTE WAS REMOVED. NO COMPONENTS WERE REVISED AT THIS TIME. DOI: (B)(6) 2014. DOE: (B)(6) 2017. RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 12166578 ↗
• InjuryMar 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PAIN.

  Patient problems: Pain

  MAUDE report 7316093 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061648, K233980. One submission often covers many models, so check the product and lot details in each record.

• Z-1219-2018 · Dec 21, 2017 · Terminated
  (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GT