UNKNOWN BONE CEMENT
Received Sep 26, 2022 · Event occurred Sep 12, 2022
Report 1818910-2022-18728 · MDR key 15485509
Device
Product problems
- Loss of or Failure to Bond
- Loss of or Failure to Bond
Patient
Male
- Wound Dehiscence
- Fall
- Unspecified Infection
- Wound Dehiscence
- Fall
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (B)(4). THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. 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 REVISED DUE TO FALL 3 TIMES ON THE KNEE, AS A RESULT, WOUND OPENED AND BECAME INFECTED. THERE WAS LOOSENING REPORTED ON THE FEMUR AND TIBIA AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI : UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: UNKNOWN.
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (B)(4) INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR MANUFACTURING RECORD EVALUATION, WAS NOT POSSIBLE AS THE REQUIRED LOT NUMBER WAS NOT PROVIDED. THE INFORMATION RECEIVED WILL BE RETAINED FOR TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.