BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 32/0, TAPER 12/14
Report
- Report Number
- 0009613350-2017-01035
- Event Type
- Injury
- Date Received
- August 8, 2017
- Date of Event
- June 15, 2016
- Report Date
- September 11, 2018
- Manufacturer
- ZIMMER GMBH
- Product Code
- LZO
- PMA / PMN Number
- PK071535
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- 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: REVISION DUE TO INFECTION / LOOSENING. EVENT SUMMARY: A FEMALE PATIENT, WAS IMPLANTED WITH TM MODULAR CUP - BIOLOX HEAD ON (B)(6) 2015 AND WAS REVISED ON (B)(6) 2016 DUE TO INFECTION AND LOOSENING OF THE ACETABULAR CUP. IT IS ADDITIONAL STATED THAT THE PATIENT FELL 17 TIMES IN 11 DAYS AFTER THE IMPLANTATION WITH ZIMMER IMPLANTS. REVIEW OF RECEIVED DATA: - PATIENT LETTER IS RECEIVED IN WHICH IT IS STATED THAT THE PATIENT HIRED AN ATTORNEY AND SHE WILL NOT SHARE THE MEDICAL DATA WITH ZIMMER BIOMET. REVIEW OF MEDICAL RECORS: PRE-OP AND HISTORY AND PHYSICAL REPORT; ADMIT DATE: (B)(6) 2015. PLANNED SURGERY: LEFT TOTAL HIP ARTHROPLASTY. HISTORY OF PRESENT ILLNESS: A 54-YEAR-OLD FEMALE WITH KNOWN DEGENERATIVE JOINT DISEASE OF THE HIP. NONOPERATIVE MEASURES HAVE FAILED TO ADEQUATELY ALLEVIATE THE ASSOCIATED SYMPTOMS¿ PATIENT NOW DESIRES THA... PAST MEDICAL HISTORY: RIGHT THA PRIMARILY IN 2005, WITH SUBSEQUENT REVISION IN 2013. IMPRESSION: DEGENERATIVE JOINT DISEASE, LEFT HIP CHRONIC PAIN. DEPRESSIVE DISORDER. THE PATIENT¿S BODY MASS INDEX IS 23.55. HEIGHT IS 5 FEET 3-1/3 INCHES. WEIGHT IS 134 POUNDS. OPERATIVE REPORT OF IMPLANTATION; DATE OF SERVICE: (B)(6) 2015. PREOPERATIVE DIAGNOSIS: DEGENERATIVE JOINT DISEASE OF THE LEFT HIP. POSTOPERATIVE DIAGNOSIS: SAME FINDINGS: SATISFACTORY RANGE OF MOTION, STABILITY AND LIMB LENGTH FOLLOWING INSERTION OF COMPONENTS. LARGE EFFUSION, LEFT HIP JOINT. INDICATION: ¿HAS BEEN EVALUATED FOR SEVER LEFT HIP PAIN ¿SHE UNDERWENT A PRIOR RIGHT TOTAL HIP ARTHROPLASTY REVISION SEVERAL YEARS AGO .... DESCRIPTION OF PROCEDURE: ¿BEGINNINGS WITH A 44MM REAMER, THE ACETABULUM WAS REAMED THE DEPTH FOLLOWED BY ENLARGING TO SIZE AND SECTION THE 50MM ACETABULAR COMPONENT. AFTER IRRIGATING WELL AND UTILIZING THE INSERTION GUIDE, THE COMPONENT WAS SEATED WITH GOOD INTERFERENCE FIT. IT WAS NOT FELT THAT ANY ACETABULAR SCREWS WERE NECESSARY. THE LINER WAS THE SEATED¿. AN A NECK SEGMENT IN 0 BALL WAS UTILIZED WHICH APPROXIMATED HER NORMAL LENGTH, WHICH PROVIDED SATISFACTORY RANGE OF MOTION AND STABILITY. THE FINAL COMPONENTS WERE PLACED AND FINAL REDUCTION WAS CARRIED OUT¿ THE PATIENT WAS SUBSEQUENTLY AWAKENED AND TRANSFERRED TO RECOVERY ROOM IN SATISFACTORY CONDITION HAVING TOLERATED THE PROCEDURE WELL. OPERATIVE REPORT OF EXPLANTATION; DATE OF SERVICE: (B)(6) 2016. PREOPERATIVE DIAGNOSIS: PAINFUL LEFT HIP ARTHROPLASTY, SECONDARY TO LOOSE ACETABULAR COMPONENT. POSTOPERATIVE DIAGNOSIS: PAINFUL LEFT HIP ARTHROPLASTY, SECONDARY TO DEEP SEPSIS AND LOOSENING OF THE FEMORAL COMPONENT. (NOTE BY INVESTIGATOR: IT SHOULD STATE ACETABULAR COMPONENT AS THE STEM WAS SOLID) FINDINGS: CONSISTENT WITH LOW-GRADE DEEP INFECTION, LEFT HIP, LOOSE ACETABULAR COMPONENT, SMALL FRACTURE OF POSTERIOR SUPERIOR RIM OF THE LINER. DESCRIPTION OF PROCEDURE: ¿ THERE WAS A SLIGHTLY CURVED, SMALL, WELL-HEALED ANTERIOR LATERAL HIP INCISION, CONSISTENT WITH ANTERIOR APPROACH TO THE HIP. THE TISSUES WERE COMPLETELY BENIGN ABOUT THE LEFT HIP, INCLUDING NO ERYTHEMA, NO WARMTH, NO INDURATION¿ THERE WAS NOTED TO BE PURULENT FLUID PRESENT IN THE JOINT SPACE. THIS HAD SOMEWHAT GRAY, SOMEWHAT ERYTHEMATOUS COLOUR. A CULTURE WAS SENT AT THIS POINT. AT THE DISTAL ASPECT OF THE INCISION ALONG THE ADDUCTOR PLAN, THERE WAS FOUND TO BE A SMALL ABSCESS, WHICH WAS DRAINED AND THOROUGHLY DEBRIDED AND IRRIGATED WELL. RETURNING TO THE ACETABULUM, INITIAL ATTEMPTS WERE MADE TO REMOVE THE ACETABULAR LINING. IN DOING, THE CUP WAS FREELY DISLODGED WITH NO INGROWN BONE NOTED. THERE WAS NO APPARENT ABNORMALITY DEEP TO THE ACETABULUM. THOROUGH IRRIGATION WAS DONE OF ALL LOOSE TISSUE AND MEMBRANE. THE DEBRIDEMENT PROCESS WAS COMPLETED FOR THE REMAINED OF THE JOINT. THE FEMORAL STEM WAS CHECKED AND FOUND TO BE SOLID. AT THIS POINT, DECISION WAS MADE TO AND IMMEDIATE EXCHANGE FOR THE INFECTION¿AFTER IRRIGATING WELL AND DRYING THE REVERSE TRUNNION THE COMPONENTS WERE PLACED. FINAL REDUCTION WAS CARRIED OUT. RANGE OF MOTION, STABILITY AND RESTORATION OF LIMB LENGTH WAS FELT TO BE SATISFACTORY. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. 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: NONSTERILE PRODUCT DUE TO STERILE BARRIER IS NOT SUFFICIENT WITHIN THE STERILITY GARANTEE =NOT POSSIBLE: THE STERILE BARRIER IS VALIDATED ACCORDING TO THE PACKAGING SPECIFICATION. INCORRECT STERILIZATION METHOD LEADS TO NON STERILE HEAD IMPLANT DUE TO INCORRECT STERILIZATION METHOD = NOT POSSIBLE: THE STERILIZATION METHOD IS VALIDATED ACCORDING TO THE STERILIZATION SPECIFICATION. NON STERILE PRODUCT DUE TO IMPROPER HANDLING DURING SURGERY DUE TO WRONG HANDLING OF DEVICE DUE TO WRONG INFORMATION = POSSIBLE: THE HANDLING OF THE DEVICE IS OUT OF ZIMMER BIOMET CONTROL. UNSTERILE PRODUCT, DAMAGED PRODUCT DUE TO INADEQUATE PACKAGING (EG. TEMPERATURE, VIBRATION, IMPACT DURING TRANSPORT OR STORAGE) = POSSIBLE: THE PACKAGING OF THE PRODUCT IS VALIDATED ACCORDING TO THE PACKAGING SPECIFICATION. NEVERTHELESS, ONE SHOULD CHECK THE PRODUCT BEFORE OPENING THE PACKAGING REGARDING THE EXISTENCE OF ANY IMPERFECTION/DEFORMATION. TRANSMISSION OF INFECTIOUS AGENTS OR MECHANICAL FAILURE DUE TO REUSE OF THE DEVICE WHICH IS ONLY INTENDED FOR SINGLE USE = POSSIBLE: IFU (CHAPTER "WARNINGS - SINGLE USE ONLY - DO NOT RE-USE" AND SYMBOL ON BOX LABEL: "NOT TO BE RE-USED") IS PROVIDED TO CUSTOMERS. HOWEVER, STILL IT IS NOT SURELY KNOWN WHETHER THE DEVICE WAS USED BEFORE OR NOT. CONCLUSION SUMMARY: THE PATIENT UNDERWENT REVISON SURGERY DUE TO INFECTION AND LOOSENING OF THE ACETABULAR COMPONENT AFTER 1 YEAR 2 MONTHS IN-VIVO TIME. NO X-RAYS OR THE DEVICES OR PHOTOS OF THE EXPLANTED IMPLANTS WERE RECEIVED. THE CONDITION OF THE COMPONENTS IS UNKNOWN. NEVERTHELESS, STERILIZATION SPECIFICATION OF THE DEVICE CERTIFIES THE SUITABILITY OF STERILIZATION. STERILIZATION CERTIFICATE IS REVIEWED. THE STERILIZATION CERTIFICATE CONFIRMS THAT THE PRODUCT WAS STERILIZED ACCORDING TO THE SPECIFICATIONS. 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. THEREFORE, IT IS NOT SUSPECTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO ANY PATIENT INFECTION. HOWEVER, THE IFU FOR ENDOPROSTHESIS STATES THAT ¿EARLY OR LATE INFECTIONS¿ ARE ¿POSSIBLE CONSEQUENCES OF AN IMPLANT¿ AND SHOULD BE CONSIDERED WHEN IMPLANTING ZIMMER BIOMET DEVICES. POSSIBLE CAUSES OF INFECTION INCLUDE CONTAMINATION OF THE PRODUCT DURING SURGERY, DAMAGE OF PACKAGING DURING TRANSPORTATION, REUSE OF THE DEVICE WHICH IS ONLY INTENDED FOR SINGLE USE AND RESTERILIZATION OF THE DEVICE (BIOLOX DELTA CERAMIC FEMORAL HEADS MUST NOT BE RESTERILIZED BY ANY METHOD). BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. 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 INFORMATION WAS RECEIVED ON AUGUST 18, 2017. THE PATIENT WILL BE PURSUING A LEGAL CLAIM. THE REVISION DATE WAS PROVIDED. NO MORE INFORMATION WAS PROVIDED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. NOTE: THIS IS A SPLIT CASE WITH ZIMMER INC., WARSAW REFERENCE NUMBER (B)(4). ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
ADDITIONAL INFORMATION WAS RECEIVED ON NOVEMBER 17, 2017. DEVICE HISTORY RECORDS: THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. EVENT DESCRIPTION: EVENT SUMMARY: A FEMALE PATIENT WAS IMPLANTED WITH TM MODULAR CUP - BIOLOX HEAD AND WAS REVISED DUE TO INFECTION AND LOOSENING. IT IS ADDITIONAL STATED THAT THE PATIENT FELL 17 TIMES IN 11 DAYS AFTER THE IMPLANTATION WITH ZIMMER IMPLANTS. REVIEW OF RECEIVED DATA: PATIENT LETTER IS RECEIVED IN WHICH IT IS STATED THAT THE PATIENT HIRED AN ATTORNEY AND SHE WILL NOT SHARE THE MEDICAL DATA WITH ZIMMER BIOMET. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. THE PRODUCT LOCATION IS UNKNOWN. REVIEW OF PRODUCT DOCUMENTATION: THE COMPATIBILITY CHECK WAS PERFORMED FROM (B)(6) AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. STERILIZATION CERTIFICATE WAS REVIEWED. THE STERILIZATION CERTIFICATE CONFIRMS THAT THE PRODUCT WAS STERILIZED ACCORDING TO THE SPECIFICATIONS. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING SAP DFMEA: UNABLE TO DISASSEMBLE HEAD FROM STEM TAPER DURING REVISION SURGERY OR EXCESSIVE DISASSEMBLY FORCE, DAMAGE TO STEM TAPER LEADS TO REVISION / LOOSENING OF PREVIOUSLY WELL FIXED STEM, DAMAGE OF BONE DUE TO INADEQUATE DESIGN OF STEM TAPER CONNECTION OR INSTRUMENTS LEADING TO HIGH DISASSEMBLY FORCES. NOT POSSIBLE: PATIENT DID NOT HAVE AN PREVIOUS IMPLANTATION SURGERY BEFORE THE INITIAL SURGERY. INCREASED FRICTION FOR CERAMIC ON CERAMIC LEADING TO LOOSENING OF COMPONENTS OR INCREASED WEAR DUE TO INADEQUATE SURFACE OR CLEARANCE OF COC COMPONENTS => NOT POSSIBLE: A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. NONSTERILE PRODUCT DUE TO STERILE BARRIER IS NOT SUFFICIENT WITHIN THE STERILITY GUARANTEE. NOT POSSIBLE: THE STERILE BARRIER IS VALIDATED ACCORDING TO THE PACKAGING SPECIFICATION. INCORRECT STERILIZATION METHOD LEADS TO NON STERILE HEAD IMPLANT DUE TO INCORRECT STERILIZATION METHOD. NOT POSSIBLE: THE STERILIZATION METHOD IS VALIDATED ACCORDING TO THE STERILIZATION SPECIFICATION. THERMAL NECROSIS AND/OR IMPLANT LOOSENING AND IMPOSSIBILITY TO USE MRI SCANNING DUE TO MRI: -MAGNETICALLY INDUCED DISPLACEMENT FORCE AND TORQUE -RADIOFREQUENCY INDUCED HEATING. IMAGE ARTIFACTS. NOT POSSIBLE: MRI INTERACTION OF THE DEVICE IS CONTROLLED VIA FOLLOWING DOCUMENTS: EVALUATION OF INTERACTIONS OF MAGNETIC RESONANCE IMAGING (MRI) MAGNETIC FIELDS. NON STERILE PRODUCT DUE TO IMPROPER HANDLING DURING SURGERY DUE TO WRONG HANDLING OF DEVICE DUE TO WRONG INFORMATION. POSSIBLE: THE HANDLING OF THE DEVICE IS OUT OF ZIMMER BIOMET CONTROL. UNSTERILE PRODUCT, DAMAGED PRODUCT DUE TO INADEQUATE PACKAGING (EG. TEMPERATURE, VIBRATION, IMPACT DURING TRANSPORT OR STORAGE). POSSIBLE: THE PACKAGING OF THE PRODUCT IS VALIDATED ACCORDING TO THE PACKAGING SPECIFICATION. NEVERTHELESS, ONE SHOULD CHECK THE PRODUCT BEFORE OPENING THE PACKAGING REGARDING THE EXISTENCE OF ANY IMPERFECTION/DEFORMATION. TRANSMISSION OF INFECTIOUS AGENTS OR MECHANICAL FAILURE DUE TO REUSE OF THE DEVICE WHICH IS ONLY INTENDED FOR SINGLE USE. POSSIBLE: SYMBOL ON BOX LABEL: "NOT TO BE RE-USED" IS PROVIDED TO CUSTOMERS. HOWEVER, STILL IT IS NOT SURELY KNOWN WHETHER THE DEVICE WAS USED BEFORE OR NOT. CONCLUSION SUMMARY: THE PATIENT UNDERWENT REVISION SURGERY DUE TO INFECTION AND LOOSENING AFTER 1 YEAR 2 MONTHS IN-VIVO TIME. NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANTS WERE RECEIVED. IN THE ABSENCE OF THE MEDICAL DATA IT IS NOT POSSIBLE TO CONFIRM THE EVENT. NEVERTHELESS, STERILIZATION SPECIFICATION OF THE DEVICE CERTIFIES THE SUITABILITY OF STERILIZATION. STERILIZATION CERTIFICATE IS REVIEWED. THE STERILIZATION CERTIFICATE CONFIRMS THAT THE PRODUCT WAS STERILIZED ACCORDING TO THE SPECIFICATIONS. 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. THEREFORE, IT IS NOT SUSPECTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO ANY PATIENT INFECTION. HOWEVER, THE IFU FOR ENDOPROSTHESIS D011500200 STATES THAT ¿EARLY OR LATE INFECTIONS¿ ARE ¿POSSIBLE CONSEQUENCES OF AN IMPLANT¿ AND SHOULD BE CONSIDERED WHEN IMPLANTING ZIMMER BIOMET DEVICES. POSSIBLE CAUSES OF INFECTION INCLUDE CONTAMINATION OF THE PRODUCT DURING SURGERY, DAMAGE OF PACKAGING DURING TRANSPORTATION, REUSE OF THE DEVICE WHICH IS ONLY INTENDED FOR SINGLE USE AND RESTERILIZATION OF THE DEVICE (BIOLOX DELTA CERAMIC FEMORAL HEADS MUST NOT BE RESTERILIZED BY ANY METHOD). BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. THEREFORE, ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. NOTE: THIS IS A SPLIT CASE WITH ZIMMER INC., (B)(4).
A PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 32/0, TAPER 12/14 ON THE LEFT SIDE ON (B)(6) 2015 AND THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016 DUE TO INFECTION AND LOOSENING.
IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 32/0, TAPER 12/14 ON THE LEFT SIDE ON (B)(6) 2015 AND THE PATIENT UNDERWENT REVISION SURGERY ON UNKNOWN DATE DUE TO INFECTION AND LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 554596 | BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 32/0, TAPER 12/14 | BIOLOX DELTA CERAMIC FEMORAL HEAD | LZO | ZIMMER GMBH | N/A | 2778788 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Hospitalization| R |