FEMORAL STEM PRESS-FIT COLLARLESS 12/14 NECK TAPER
Report
- Report Number
- 0001822565-2021-02475
- Event Type
- Injury
- Date Received
- September 7, 2021
- Date of Event
- October 21, 2020
- Report Date
- November 19, 2021
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- JDI
- PMA / PMN Number
- K200823
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT OF DEEP INFECTION OCCURRED GREATER THAN 90 DAYS¿ POST IMPLANTATION. IT IS NOTED THAT THE FEMORAL IMPLANT WAS PLACED DURING INITIAL PROCEDURE AND A REVISION SURGERY OF OTHER HIP COMPONENTS WAS PERFORMED AND THEY RETAINED THE FEMORAL COMPONENT. THE FEMORAL COMPONENT WAS NOT EXPLANTED/REVISED TILL THE PATIENTS SECOND, FIRST STAGE REVISION WHEN INFECTION WAS IDENTIFIED AND SPACERS PLACED. DURING THE INVESTIGATION PROCESS A REVIEW OF THE STERILE CERTIFICATIONS WERE REVIEWED AND FOUND TO BE CONFORMING WITH NO APPLICABLE DEVIATIONS. DEVICES WERE VERIFIED TO HAVE GONE THROUGH ACCEPTABLE STERILIZATION PROCESS FOLLOWING ISO/AAMI/ASTM & EU PUBLISHED GUIDELINES. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF ZIMMER BIOMET, SUCH AS EXTERNAL FACTORS, I.E. HOSPITAL/SURGICAL ENVIRONMENT, PROVIDER RELATED RISK FACTORS, AND/OR PATIENT COMORBIDITIES/RISK FACTORS. AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUES IDENTIFIED AFFECTING IMPLANT SAFETY OR EFFECTIVENESS, THEREFORE IMPLANTED PRODUCTS ARE NOT IDENTIFIED AS THE SOURCE OR CONTRIBUTING TO THE REPORTED INFECTION. PATIENT IS NOTED TO HAVE ELEVATED BMI OF 49.6, MORBID OBESITY, THIS INCREASES THE RISK FOR DEVELOPING INFECTIONS. IT SHOULD BE NOTED THE FIRST REVISION SURGERY OF ALL COMPONENTS EXCEPT FOR FEMORAL COMPONENT, INCREASES THE RISK FOR DEVELOPING AN INFECTION. 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.
NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.
(B)(4). CONCOMITANT PRODUCTS: 110010265 ¿ G7 MULTIHOLE CUP - 3863830. 110017220 - G7 LINER ¿ 3579795. 010000997 ¿ G7 SCREW ¿ 3865243. 010000997 ¿ G7 SCREW ¿ 3847793. 010000997 ¿ G7 SCREW ¿ 3874188. 010000997 ¿ G7 SCREW ¿ 3855555. 010000999 ¿ G7 SCREW ¿ 3871319. 010001001 ¿ G7 SCREW ¿ 3855562. 00877703603 ¿ BIOLOX DELTA HEAD ¿ 2790040. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR THE INVESTIGATION AS THE DEVICE WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO PAIN AND METAL RELATED PATHOLOGY APPROXIMATELY 7 YEARS POST IMPLANTATION. SUBSEQUENTLY, THE PATIENT VISITED THE ER DUE TO DISLOCATIONS, PAIN AND SWELLING WITH NO NOTED MEDICAL INTERVENTION. THE PATIENT THEN UNDERWENT A SECOND REVISION APPROXIMATELY 4 YEARS LATER DUE TO CHRONIC INFECTION. ALL DEVICES WERE REMOVED AND REPLACED WITH SPACERS. APPROXIMATELY 1 MONTH LATER THE PATIENT STILL HAD ONGOING INFECTION DESPITE USE OF ANTIBIOTICS, SO NEW SPACERS WERE IMPLANTED ALONG WITH WIRES. THERE IS NO REPORT OR NEW PERMANENT IMPLANTS BEING IMPLANTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1330603 | FEMORAL STEM PRESS-FIT COLLARLESS 12/14 NECK TAPER | PROSTHESIS, HIP | JDI | ZIMMER BIOMET, INC. | N/A | 61209287 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Hospitalization| R |