Scorpio 73-3508Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327033885), received between Nov 8, 2023 and Nov 8, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Discolored” (3 reports).

2 FDA recall records name this device's identifier, 2 still open.

7 other recalls cover devices cleared under the same FDA submission (K051948, K052917, K243817, K252898, K972967); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. 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-3206-2026 · Root cause: Process change control · FDA record ↗

2. Dec 1, 2023Open, Classified

   Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

   Z-0895-2024 · Root cause: Nonconforming Material/Component · FDA record ↗

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.

• MalfunctionNov 8, 2023Material Discolored; Material Discolored

  IMPLANT REFERENCE NUMBER 73-3508 WITH LOT NUMBERS 53TI AND Y7X2 HAD A YELLOW RING AROUND THE DIAMETER OF THE PATELLA IMPLANT WHEN OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18096795 ↗
• MalfunctionNov 8, 2023Material Discolored; Material Discolored

  IMPLANT REFERENCE NUMBER (B)(4) WITH LOT NUMBERS 53TI AND Y7X2 HAD A YELLOW RING AROUND THE DIAMETER OF THE PATELLA IMPLANT WHEN OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18096793 ↗
• MalfunctionNov 8, 2023Material Discolored; Material Discolored

  IMPLANT REFERENCE NUMBER 73-3508 WITH LOT NUMBERS 53TI AND Y7X2 HAD A YELLOW RING AROUND THE DIAMETER OF THE PATELLA IMPLANT WHEN OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18096792 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051948, K052917, K243817, K252898, K972967. One submission often covers many models, so check the product and lot details in each record.

• Z-3197-2026 · Jul 30, 2026 · Open, Classified
  ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE P/S 82-3-0318 SCORPIO + MOBILE BEARING PCS 78-5-0910 SCORPIO C-DOME PAT
• Z-0896-2024 · Dec 1, 2023 · Open, Classified
  SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3708
• Z-0897-2024 · Dec 1, 2023 · Open, Classified
  SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710
• Z-0893-2024 · Dec 1, 2023 · Open, Classified
  SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3110
• Z-0900-2024 · Dec 1, 2023 · Open, Classified
  Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0910
• Z-0894-2024 · Dec 1, 2023 · Open, Classified
  SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3308
• Z-0606-2012 · Aug 17, 2011 · Terminated
  Eius Unicompartmental Knee System Stryker Howmedica Osteonics Corp. Howmedica International S. de R.L., Raheen Business Park, Limerick, Ireland. Intended for use in Unicompartment