CER BIOLOXD OPTION HD 28MM
Report
- Report Number
- 0001825034-2019-01555
- Event Type
- Injury
- Date Received
- April 5, 2019
- Date of Event
- February 13, 2018
- Report Date
- June 1, 2021
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- LZO
- PMA / PMN Number
- K082996
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI : (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS STATING THE PATIENT WAS EXPERIENCING SYMPTOMS OF INFECTION. SURGEON NOTES TISSUE APPEARING TO BE OBVIOUS INFECTION AND PERFORMED FLUID IRRIGATION AND DEBRIDEMENT. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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.
DURING THE INVESTIGATION PROCESS A REVIEW OF THE STERILE CERTIFICATIONS WAS PERFORMED AND STERILE CERTS WERE 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. OF NOTE, THE IDENTIFIED INFECTIOUS ORGANISM, MRSA, IS A COMMON BACTERIA OF THE SKIN & NARES (1 IN 30 PEOPLE OR 1 IN 20 HEALTHCARE WORKERS) AND IS SPREAD VIA DIRECT CONTACT WITH A PERSON WHO HAS MRSA OR CONTACT WITH A SURFACE CONTAMINATED BY A PERSON WHO HAS MRSA. MRSA CAN BE FOUND IN HEALTHCARE FACILITIES, SCHOOLS, STORES, HOMES, WORKPLACES, - ANYWHERE THERE ARE PEOPLE. MRSA CARRIERS CAN LIVE WITH NO SYMPTOMS FOR YEARS AND MAY NEVER BECOME INFECTED. 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 EVENT INFORMATION TO REPORT AT THIS TIME.
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
(B)(4). CONCOMITANT MEDICAL PRODUCTS: 650-1068 ¿ BIOLOX DELTA TAPER ¿ 2900909, EP-200152 ¿ E1 ACTIVE ARTICULATION BEARING ¿ 203840, 11-103201 ¿ TAPERLOC STEM ¿ 009340, US157852 ¿ M2A MAGNUM CUP ¿ 018300. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 01554, 0001825034 - 2019 - 01556.
IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 8 YEARS POST IMPLANTATION. APPROXIMATELY 1 MONTH POST REVISION, THE PATIENT WAS EXPERIENCING SYMPTOMS OF INFECTION. CULTURES IDENTIFIED BACTERIA AS (B)(6). IRRIGATION AND DÉBRIDEMENT WAS PERFORMED ALONG WITH EXCHANGE OF TAPER ADAPTER, CERAMIC HEAD AND BEARING. PATIENT WAS ALSO PUT ON A LONG TERM IV AND ORAL ANTIBIOTIC THERAPY. 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 |
|---|---|---|---|---|---|---|---|
| 281308 | CER BIOLOXD OPTION HD 28MM | PROSTHESIS, HIP | LZO | ZIMMER BIOMET, INC. | N/A | 2897818 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |