inforMED
InjuryMBV

BIOMET ILOK PRI TIB TRAY 75MM

Received Mar 4, 2019 · Event occurred Jan 29, 2019

Report 0001822565-2019-00972 · MDR key 8385897

Device

Generic name

Prosthesis, Knee

Catalog number

141214

Lot number

387980

Product problems

  • Insufficient Device Problem Information
  • Insufficient Device Problem Information

Patient

62 YR

  • Pain
  • Ambulation or Postural Difficulties
  • Pain
  • Ambulation or Postural Difficulties

Narrative

Additional Manufacturer Narrative

IT WAS DETERMINED THIS REPORTING WAS SENT UNDER INCORRECT MFR#. PLEASE VOID THIS SUBMISSION AND REFER TO 0001825034 - 2019 - 00964.

Description of Event or Problem

IT WAS DETERMINED THIS REPORTING WAS SENT UNDER INCORRECT MFR#. PLEASE VOID THIS SUBMISSION AND REFER 0001825034 - 2019 - 00964.

Additional Manufacturer Narrative

(B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2019 - 00969, 0001822565 - 2019 - 00974, 0001822565 - 2019 - 00975. PRODUCT REMAINS IMPLANTED.

Description of Event or Problem

IT WAS REPORTED THAT PATIENT EXPERIENCED FOOT DROP ON THE RIGHT KNEE. CONTINUE TO EXPERIENCE PAIN, DIFFICULTY WALKING. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.