CEMENTRALIZER 12.0
Received May 6, 2022 · Event occurred Apr 20, 2022
Report 1818910-2022-08318 · MDR key 14307258
Device
Generic name
Hip Miscellaneous : Cement Centralizer/plug
Manufacturer
Depuy Orthopaedics Inc UsModel number
1376-21-000Catalog number
137621000
Lot number
JK8868
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
77 YR · Female
- Unspecified Infection
- Unspecified Infection
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT HAD A HEMI DONE IN (B)(6) 2021, PATIENT IS INFECTED. REMOVED IMPLANTS AND CEMENTED IN ANOTHER HEMI WITH ANTIBIOTIC IMPREGNATED CEMENT. I HAVE NO OTHER INFORMATION. THERE IS NO REPORTED LOOSENING. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.