ALLOCLASSIC SL STEM 1 12/14
Report
- Report Number
- 0009613350-2018-00471
- Event Type
- Injury
- Date Received
- April 26, 2018
- Date of Event
- May 22, 2015
- Report Date
- September 14, 2018
- Manufacturer
- ZIMMER GMBH
- Product Code
- LZO
- PMA / PMN Number
- PK030373
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
Narratives
DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: INFECTION. EVENT SUMMARY: IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY 15 DAYS POST IMPLANTATION DUE TO DEEP INFECTION OF THE HIP. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS; ACCORDING TO THE INFORMATION RECEIVED IT WAS DISCARDED AT THE HOSPITAL. REVIEW OF PRODUCT DOCUMENTATION: THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING DFMEA (FOR VARIALL SHELL): INFECTION DUE TO FAILURE OF STERILIZATION PROCEDURE AT SUPPLIER DUE TO DESIGN OF THE DEVICE: NOT POSSIBLE: A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. INFECTION DUE TO FAILURE OF STERILIZATION PROCEDURE DUE TO SUPPLIER PROCESS: NOT POSSIBLE: A SYSTEMATIC ISSUE WITH PROCESS WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. INFECTION DUE TO PROPOSED RESTERILIZATION PROCEDURES IN IFU DO NOT PROVIDE STERILITY: POSSIBLE: THE IFU DESCRIBES IN CHAPTER "STERILIZATION INSTRUCTIONS" HOW TO PROCEED WITH THE DEVICE. HOWEVER, IT IS NOT KNOWN IF PROCEDURE WAS FOLLOWED. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED WITH CERTAINTY. TRANSMISSION OF INFECTIOUS AGENTS, INFECTION DUE TO REUSE OF THE DEVICE WHICH IS ONLY INTENDED FOR SINGLE USE: NOT POSSIBLE: THE IFU DESCRIBES IN CHAPTER "STERILIZATION INSTRUCTIONS" HOW TO PROCEED WITH THE DEVICE: "DO NOT REUSE DEVICES LABELLED FOR SINGLE USE ONLY". NO INFORMATION RECEIVED, THAT AN EXPLANTED IMPLANT IS USED FOR NEW IMPLANTATION SURGERY. THEREFORE, THIS CAUSE CAN BE EXCLUDED. INFECTION DUE TO RESTERILIZATION PROCEDURES (DESCRIBED IN IFU) NOT FOLLOWED BY HOSPITAL STAFF (OFF LABEL USE): POSSIBLE: THE IFU DESCRIBES IN CHAPTER "STERILIZATION INSTRUCTIONS" HOW TO PROCEED WITH THE DEVICE. HOWEVER, IT IS NOT KNOWN IF PROCEDURE WAS FOLLOWED. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. ROOT CAUSE DETERMINATION USING RMW: BIOLOGICAL CONTAMINATED DEVICE IS IMPLANTED DUE TO CLEANING PROCESS FAILURE NOT POSSIBLE: A SYSTEMATIC ISSUE WITH THE CLEANING PROCESS WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. THEREFORE, THIS CAUSE CAN BE EXCLUDED. BIOLOGICAL CONTAMINATED DEVICE IS IMPLANTED DUE TO STERILIZATION PROCESS FAILURE NOT POSSIBLE: A SYSTEMATIC ISSUE WITH THE STERILIZATION PROCESS WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. THEREFORE, THIS CAUSE CAN BE EXCLUDED. BIOLOGICAL CONTAMINATED DEVICE IS IMPLANTED DUE TO CONTAMINATED DEVICE DUE TO PACKAGING FAILURE NOT POSSIBLE: A SYSTEMATIC ISSUE WITH THE PACKAGING WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. THEREFORE, THIS CAUSE CAN BE EXCLUDED. BIOLOGICAL CONTAMINATED DEVICE IS IMPLANTED DUE TO INADEQUATE TRANSPORT/HANDLING/STORAGE CONDITION: POSSIBLE, THE HANDLING AND STORAGE OF THE COMPONENT IS OUTSIDE OF ZIMMER BIOMET CONTROL. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED.- BIOLOGICAL CONTAMINATED DEVICE IS IMPLANTED DUE TO INADEQUATE STERILIZATION PROCEDURE NOT POSSIBLE: A SYSTEMATIC ISSUE WITH STERILIZATION PROCEDURE WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. THEREFORE, THIS CAUSE CAN BE EXCLUDED. CHEMICAL CONTAMINATED DEVICE IS IMPLANTED DUE TO INADEQUATE CLEANING PROCEDURE NOT POSSIBLE: A SYSTEMATIC ISSUE WITH CLEANING PROCEDURE WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. THEREFORE, THIS CAUSE CAN BE EXCLUDED. BIOLOGICAL CONTAMINATED DEVICE IS IMPLANTED DUE TO EXPLANTED IMPLANT IS USED FOR NEW IMPLANTATION SURGERY NOT POSSIBLE: THE IFU DESCRIBES IN CHAPTER "WARNINGS" HOW TO PROCEED WITH THE DEVICE: "IMPLANTS ARE FOR SINGLE USE ONLY. REUSE OF A SINGLE USE DEVICE THAT HAS COME IN CONTACT WITH BLOOD, BONE, TISSUE OR OTHER BODY FLUIDS MAY LEAD TO PATIENT OR USER INJURY. POSSIBLE RISKS ASSOCIATED WITH REUSE OF A SINGLE USE DEVICE INCLUDE, BUT ARE NOT LIMITED TO, MECHANICAL FAILURE AND TRANSMISSION OF INFECTIOUS AGENTS.". NO INFORMATION RECEIVED, THAT AN EXPLANTED IMPLANT IS USED FOR NEW IMPLANTATION SURGERY. THEREFORE, THIS CAUSE CAN BE EXCLUDED. ROOT CAUSE DETERMINATION USING RMW (FOR BIOLOX DELTA HEAD): NON-STERILE DEVICE IS IMPLANTED DUE TO STERILIZATION PROCESS FAILURE NOT POSSIBLE: A SYSTEMATIC ISSUE WITH THE STERILIZATION PROCESS WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT . THEREFORE, THIS CAUSE CAN BE EXCLUDED. NON-STERILE DEVICE IS IMPLANTED DUE TO CONTAMINATED DEVICE DUE TO PACKAGING FAILURE NOT POSSIBLE: A SYSTEMATIC ISSUE WITH THE PACKAGING DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT . THEREFORE, THIS CAUSE CAN BE EXCLUDED. NON-STERILE DEVICE IS IMPLANTED DUE TO SURGEON RESTERILIZES HEAD NOT POSSIBLE: IFU CHAPTER. "RESTERILIZATION INFORMATION" BIOLOX DELTA CERAMIC FEMORAL HEADS MUST NOT BE RESTERILIZED BY ANY METHOD. NO INFORMATION RECEIVED, THAT THE SURGEON RESTERIALIZED THE DEVICE. THEREFORE, THIS CAUSE CAN BE EXCLUDED. NON-STERILE DEVICE IS IMPLANTED, CROSS CONTAMINATION DUE TO EXPLANTED CERAMIC HEAD IS REUSED WITH THE SAME OR NEW FEMORAL STEM NOT POSSIBLE: IFU CHAPTER ¿WARNINGS¿ RE-USE OF A SINGLE USE DEVICE THAT HAS COME INTO CONTACT WITH BLOOD, BONE, TISSUE OR OTHER BODY FLUIDS MAY LEAD TO PATIENT OR USER INJURY. POSSIBLE RISKS ASSOCIATED WITH RE-USE OF A SINGLE USE DEVICE INCLUDE, BUT ARE NOT LIMITED TO, MECHANICAL FAILURE AND TRANSMISSION OF INFECTIOUS AGENTS. IN ADDITION, NO INFORMATION RECEIVED, THAT A SINGLE USE DEVICE WAS REUSED. THEREFORE, THIS CAUSE CAN BE EXCLUDED. NON-STERILE DEVICE IS IMPLANTED DUE TO PACKAGING IS DAMAGED DUE TO INADEQUATE HANDLING DURING TRANSPORTATION, STORAGE: POSSIBLE, THE HANDLING AND STORAGE OF THE COMPONENT IS OUTSIDE OF ZIMMER BIOMET CONTROL. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. NON-STERILE DEVICE IS IMPLANTED, CROSS CONTAMINATION DUE TO INAPPROPRIATE INFORMATION ON PACKAGING LABEL OR NOT LEGIBLE PACKAGING LABEL LEADS TO INCORRECT USE OF IMPLANT (E.G. USE OF EXPIRED PRODUCT, RESTERILIZATION OF HEAD) NOT POSSIBLE: A SYSTEMATIC ISSUE WITH THE INADEQUATE LABELLING WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. THEREFORE, THIS CAUSE CAN BE EXCLUDED. CONCLUSION SUMMARY: IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY 15 DAYS POST IMPLANTATION DUE TO INFECTION. THE GAMMA STERILIZATION SPECIFICATION OF THE DEVICE CERTIFIES THE SUITABILITY OF STERILIZATION. THE IRRADIATION CERTIFICATES OF THE AFFECTED LOTS HAVE BEEN REVIEWED AND WERE FOUND TO BE ACCORDING TO SPECIFICATION. THEREFORE, IT CAN BE EXCLUDED THAT AN UNSTERILE DEVICE CAUSED THE INFECTION. MOREOVER, NO TREND ON INFECTION HAS BEEN OBSERVED FOR THOSE PRODUCTS. SINGLE-USE, STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER BIOMET ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. IT IS HIGHLY UNLIKELY THAT A DISADVANTAGEOUS PRODUCT DESIGN FAVOURED OR CONTRIBUTED TO THE INFECTION. HOWEVER, THE APPROPRIATE IFUS FOR ENDOPROSTHESIS STATES THAT ¿EARLY OR LATE INFECTIONS¿ ARE ¿POSSIBLE CONSEQUENCES OF AN IMPLANT¿ AND SHOULD BE CONSIDERED WHEN IMPLANTING ZIMMER BIOMET DEVICES. NEVERTHELESS, POSSIBLE CAUSES OF INFECTION INCLUDE WRONG HANDLING OF DEVICE DUE TO WRONG INFORMATION, WRONG RESTERILIZATION PROCEDURES FOR STERILE DELIVERED PARTS OR PACKAGING FAILURE DURING TRANSPORTATION. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 32/0, TAPER 12/14, (B)(4), LOT# 2791324; ALLOCLASSIC SL STEM 1 12/14, (B)(4), LOT#2632897; ALLOCLASSIC VARIALL BIOLOX DELTA, INSERT, II/32, (B)(4), LOT#2770510. THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2018-00397 AND 0009613350-2018-00402. NOTE: THIS IS A SPLIT CASE WITH ZIMMER INC., (B)(4). (B)(4).
IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL HIP ARTHROPLASTY AND WAS REVISED DUE TO DEEP HIP INFECTION AFTER 15 DAYS IN VIVO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 308834 | ALLOCLASSIC SL STEM 1 12/14 | ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM | LZO | ZIMMER GMBH | N/A | 2632897 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization| R |