ECHO BI-METRIC FEMORAL STEM
Report
- Report Number
- 0001825034-2019-01195
- Event Type
- Injury
- Date Received
- March 13, 2019
- Date of Event
- February 15, 2019
- Report Date
- October 11, 2023
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- LPH
- PMA / PMN Number
- K143009
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6 COMPONENT CODE: MECHANICAL (G04) - STEM. COMPLAINT CONFIRMED BASED ON EVALUATION OF PROVIDED MEDICAL RECORDS. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS/THESE ITEM(S) AND THE REPORTED PART AND LOT COMBINATION(S). MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: NONDISPLACED FRACTURE OF MEDIAL CALCAR OF FEMORAL NECK. FORMAL PT PRESCRIBED, D/C HOME SAME DAY, ASPIRIN FOR DVT PROPHYLAXIS. NEUTRAL SATISFACTION WITH HIP, REPORTS NO ISSUES WITH HIP, LEG LENGTHS EQUAL. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION. 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.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED DURING INITIAL LEFT HIP ARTHROPLASTY A NONDISPLACED FRACTURE OF MEDIAL CALCAR OF FEMORAL NECK. POST OP X-RAY IDENTIFIED SUBSIDENCE OF THE INTRAOPERATIVE MEDIAL CALCAR FRACTURE. ONE YEAR POST OP PATIENT REPORTED PARTICIPATING IN MILD ACTIVITIES, NO ISSUES WITH HIP, LEG LENGTHS EQUAL. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
(B)(4). CONCOMITANT MEDICAL PRODUCTS: 110010244 G7 SHELL 6415143; 010000998 G7 SCREW 6440180; 01000849 G7 NEUTRAL LINER 6366874; 12-115114 BIOLOX HEAD 2921994. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT WAS REPORTED DURING AN INITIAL HIP ARTHROPLASTY THAT AN INTRAOPERATIVE NON-DISPLACED FRACTURE OF MEDIAL CALCAR OF FEMORAL NECK OCCURRED. CERCLAGE CABLES WERE PLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 210468 | ECHO BI-METRIC FEMORAL STEM | PROSTHESIS, HIP | LPH | ZIMMER BIOMET, INC. | N/A | 008780 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention | SEE H10 NARRATIVE. |