E-POLY 36MM +3 MAXROM LINER SZ23
Received May 1, 2018 · Event occurred Apr 11, 2018
Report 0001825034-2018-03015 · MDR key 7477726
Device
Generic name
Hip Prosthesis
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
EP-108223
Lot number
247000
Product problems
- Detachment Of Device Component
- Device Dislodged or Dislocated
- Detachment Of Device Component
- Device Dislodged or Dislocated
Patient
64 YR
- Joint Dislocation
- Joint Dislocation
Narrative
Additional Manufacturer Narrative
(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO HOSPITAL DISCARDING AS BIOHAZARD. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: BIOMET REGEN/RNGLC+ LTD 52MM SZ 23, ITEM #: PT-116052, LOT#: 315700, BIOMET CER BIOLOXD MOD HD 36MM STD NK, ITEM#: 12-115121, LOT#: 2911053, BIOMET TPRLC 133 FP TYPE1 PPS HO 7.0, ITEM#: 51-101070, LOT#: 2711253. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 03017, 0001825034 - 2018 - 03018.
Description of Event or Problem
IT WAS REPORTED PATIENT UNDERWENT A HIP REVISION 2 DAYS POST-OP DUE TO DISASSOCIATION AND DISLOCATION. NO ANOMALIES WERE NOTICED DURING THE INITIAL SURGERY, BUT SURGEON BELIEVES PATIENT'S ABNORMALLY HIGH BODY MASS INDEX WAS A CONTRIBUTING FACTOR. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Additional Manufacturer Narrative
REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
IT WAS REPORTED PATIENT UNDERWENT A HIP REVISION 2 DAYS POST-OP DUE TO DISASSOCIATION. NO ANOMALIES WERE NOTICED DURING THE INITIAL SURGERY, BUT SURGEON BELIEVES PATIENT'S ABNORMALLY HIGH BODY MASS INDEX WAS A CONTRIBUTING FACTOR. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.