inforMED
InjuryHTG

UNKNOWN KNEE PATELLA

Received Aug 2, 2018 · Event occurred Jul 6, 2018

Report 1818910-2018-65610 · MDR key 7742023

Device

Generic name

Knee Patella

Catalog number

UNK KNEE PATELLA

Lot number

NI

Product problems

  • Noise, Audible
  • Noise, Audible

Patient

70 YR

  • Pain
  • Loss of Range of Motion
  • Scarring
  • Not Applicable
  • Pain
  • Loss of Range of Motion
  • Scarring
  • Not Applicable

Narrative

Additional Manufacturer Narrative

(B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative

(B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

PATIENT WAS DOING EXTREMELY WELL UNTIL APPROXIMATELY (B)(6) 2018, WHERE HE REPORTED DOING A "MINOR EXTENSION ACTION WHEN PUSHING A TROLLEY. HE HAD IMMEDIATE ONSET OF PAIN. HE IS UNABLE TO WALK UP AND DOWN STAIRS WITHOUT PAIN AND AN ABLE TO SIT FOR PROLONGED PERIODS OF TIME. HE IS AWARE OF A CLICKING AND CATCHING SENSATION. X RAYS APPEAR TO SHOW THAT THE COMPONENTS ARE WELL FIXED AND THAT THERE MAY BE A SLIGHTLY OBLIQUE RESECTION OF THE PATELLA WHEN THE PATELLA WAS RESURFACED AT TIME OF PRIMARY SURGERY. A DECISION HAS BEEN MAKE TO OPEN THE KNEE AND REMOVE THE EXISTING PATELLA, RECUT THE PATELLA BONE AND THEN RESURFACE THE PATELLA. ON OPENING THE KNEE, ALL COMPONENTS WERE WELL FIXED. SCAR TISSUE SURROUNDED THE PATELLA BUTTON. THE KNEE WAS SLIGHTLY LOOSE THROUGH THE RANGE OF MOTION, THE POLY WAS REMOVED AND UP SIZED TO A THICKER 12.5MM INSERT. PATELLA WAS REMOVED AND REPOSITIONED. A NEW 41MM PATELLA WAS INSERTED.