CEMENTRALIZER 12.0
Received Apr 3, 2019
Report 1818910-2019-89509 · MDR key 8478283
Device
Generic name
Hip Miscellaneous : Cement Centralizer/plug
Manufacturer
Depuy Orthopaedics, Inc. 1818910Catalog number
137621000
Lot number
C61LC1000
Product problems
- Loss of or Failure to Bond
- Loss of or Failure to Bond
Patient
Not reported
- Inadequate Osseointegration
- Inadequate Osseointegration
Narrative
Additional Manufacturer Narrative
IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.
Description of Event or Problem
PPF ALLEGES DISLOCATION AND LOOSENING OF STEM AFTER FIRST REVISION. DOI: (B)(6) 2009, DOR: NONE REPORTED, (RIGHT HIP).
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER RELATED REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT CODE/LOT NUMBER COMBINATION SINCE RELEASE FOR DISTRIBUTION. BASED ON PREVIOUS INVESTIGATIONS, THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.