CEMENTRALIZER 11.0
Received Dec 18, 2017 · Event occurred Nov 26, 2017
Report 1818910-2017-51852 · MDR key 7125127
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
69 YR
- Unspecified Infection
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
(B)(4). INVESTIGATION SUMMARY NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) 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.
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
DER STATES PT HAD ORIGINAL SURGERY (B)(6) 2017. ON (B)(6) 2017 PATIENT HAD HEAD AND LINER EXCHANGE FOR INFECTION. PATIENT STILL INFECTED SO SURGEON REMOVED ALL COMPONENTS AND PUT IN ANTIBIOTIC SPACER. IT ALSO STATE THAT PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL STEM AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT IS USED. DOI: (B)(6) 2017; DOR: (B)(6) 2017; HEAD AND LINER: (B)(6) 2017; LEFT HIP.