LOSPA Total Knee System 01.10.007Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08806373820182), received between Jun 1, 2016 and Jun 1, 2016 — classified as 1 injury.

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

2 other recalls cover devices cleared under the same FDA submission (K110404, K130673); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 1, 2016Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT HAD A TOTAL KNEE REPLACEMENT IN (B)(6) 2012. AND THEN, THE PATIENT STATED THAT HER KNEE WAS CROOKED, SWOLLEN AND PAINFUL. ON (B)(6) 2014, SHE HAD REVISION WITH OTHER COMPANY'S PRODUCTS, AND WAS STILL IN SEVERE PAIN AND TROUBLE IN WALKING.

  Patient problems: Arthralgia; Joint Swelling; Limited Mobility Of The Implanted Joint

  MAUDE report 5693646 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110404, K130673. One submission often covers many models, so check the product and lot details in each record.

• Z-1935-2024 · Mar 29, 2024 · Open, Classified
  LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: Patella
• Z-1934-2024 · Mar 29, 2024 · Open, Classified
  LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert