HATCP STEM POR TIB PLT
Report
- Report Number
- 0001822565-2024-00750
- Event Type
- Injury
- Date Received
- March 5, 2024
- Date of Event
- February 16, 2024
- Report Date
- June 7, 2024
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- MBH
- PMA / PMN Number
- K041100
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). TWO (2) DEVICE LOT #S WERE PROVIDED BY THE REPORTER; OF THESE, ONLY ONE (1) WAS REPORTED TO BE REVISED DUE TO TIBIA LOOSENING. IT IS UNKNOWN WHICH EXACT DEVICE ENCOUNTERED THIS ISSUE, IT IS ONE OF THE FOLLOWING: ITEM#: 65598203702, LOT#: 61216057 MANUFACTURE DATE: MAR 23, 2009 STERILE EXPIRY DATE: APR 30, 2014 UDI: N/A 510K: K041100, PRO CODE: MBH. OR ITEM#: 65598203702, LOT#: 61348069 MANUFACTURE DATE: MAR 23, 2009 STERILE EXPIRY DATE: OCT 31, 2014 UDI: N/A 510K: K041100, PRO CODE: MBH D10 - MEDICAL PRODUCT: SELF-TAPPING BONE SCREW 6.5 MM DIA. 20 MM LENGTH CATALOG # 00511007020 LOT # 60579568 SELF-TAPPING BONE SCREW 6.5 MM DIA. 20 MM LENGTH CATALOG # 00511007020 LOT # 60746532 SELF-TAPPING BONE SCREW 6.5 MM DIA. 20 MM LENGTH CATALOG # 00511007020 LOT # 60786197 SELF-TAPPING BONE SCREW 6.5 MM DIA. 20 MM LENGTH CATALOG # 00511007020 LOT # 60652013 SELF-TAPPING BONE SCREW 6.5 MM DIA. 25 MM LENGTH CATALOG # 00511007025 LOT # 61197945 QTY 3 SELF-TAPPING BONE SCREW 6.5 MM DIA. 25 MM LENGTH CATALOG # 00511007025 LOT # 61227792 ARTICULAR SURFACE USE WITH PLATE 3,4 SIZE YELLOW/C-H 10 MM HEIGHT CATALOG # 00595203010 LOT # 61364210 HEADLESS SCREW 48 MM LENGTH CATALOG # 00579104200 LOT # 61228516 HEADLESS SCREW 48 MM LENGTH CATALOG # 00579104200 LOT # 61366972 HEADLESS SCREW 48 MM LENGTH CATALOG # 00579104200 LOT # 61207166 HEADLESS SCREW 48 MM LENGTH CATALOG # 00579104200 LOT # 61333319 QTY 3 HEADLESS SCREW 48 MM LENGTH CATALOG # 00579104100 LOT # 61358541 HEADLESS SCREW 48 MM LENGTH CATALOG # 00579104100 LOT # 61344735 HEADLESS SCREW 48 MM LENGTH CATALOG # 00579104100 LOT # 61333317 QTY 2 ARTICULAR SURFACE USE WITH PLATE 3,4 SIZE YELLOW/C-H 10 MM HEIGHT CATALOG # 00595203010 LOT # 61126923 CRUCIATE RETAINING CR-FLEX GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT POROUS CATALOG # 00575201501 LOT # 61319372 CRUCIATE RETAINING CR-FLEX GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT POROUS CATALOG # 00575201502 LOT # 61161530 CAS FIX FLUTED 3.2DIA X 150 CATALOG # 20800000001 LOT # UNK QTY 5 NAVITRACKER KT A KNEE & SPINE ITEM # 20800000007 LOT # 37710F09 ORTHOSOFT CAS BLANK CD ITEM # ORTHOCASCD QTY 2 G2: AUSTRALIA H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE REQUESTED BUT NOT RETURNED BY HOSPITAL. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H1, H2, H3, H6, H10. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.
IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE FOURTEEN YEARS POST IMPLANTATION DUE TO TIBIAL LOOSENING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 145051 | HATCP STEM POR TIB PLT | PROSTHESIS KNEE | MBH | ZIMMER BIOMET, INC. | N/A | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Female | Hospitalization| R |