BIOLOX OPTION, HEAD, M,36/0, TAPER 12/14
Report
- Report Number
- 0009613350-2017-01766
- Event Type
- Injury
- Date Received
- December 20, 2017
- Date of Event
- March 20, 2012
- Report Date
- August 6, 2018
- Manufacturer
- ZIMMER GMBH
- Product Code
- LZO
- PMA / PMN Number
- PK073567
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- ATTORNEY
Narratives
CONCOMITTANT MEDICAL DEVICES: - REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 16/260, REF# 01.00405.316, LOT#:2375186 - REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 85, TAPER 12/14, REF# (B)(4), LOT#:2394032 THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: - 0009613350- 2017-01764 - 0009613350- 2017-01765 - 0009613350- 2017-01766 DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: INFECTION REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED, THAT A PATIENT UNDERWENT INITIAL SURGERY WITH DUROM - REVITAN STEM IMPLANTED ON FEBRUARY 11, 2008 AND EXPERIENCED METALLOSIS. THUS, PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2012 TO EXCHANGE DUROM WITH MODULAR CUP-BIOLOX HEAD (THIS EVENT IS FILED IN CPT130026931, 9613350-2013-02257); IN THIS REVISION SURGERY THE REVITAN STEM STAYED IN SITU. LATER, ON MARCH 20, 2012, THE PATIENT EXPERIENCED INFECTION AND UNDERWENT SECOND REVISION ON AUGUST 03, 2012 TO EXCHANGE ALL IMPLANTS. THIS IS A SPLIT CASE WITH ZIMMER INC., WARSAW (CUP) WITH REFERENCE NUMBER CMP-0352509, 0001822565-2017-08477. REVIEW OF RECEIVED DATA A X-RAY DATED DECEMBER 9, 2015 (3 YEARS POST IMPLANTATION) WAS RECEIVED. NO EVALUATION OF THIS PICTURE WAS DONE, SINCE IT IS NOT PART OF THE CASE AT HAND FOR THE REVISION DUE TO INFECTION ON AUGUST 3, 2012. - A LEGAL DOCUMENT WITH SURGICAL AND DOCTOR REPORTS WAS RECEIVED FOR REVIEW. SURGICAL REPORT, DATE OF SURGERY: FEBRUARY 11, 2008 (THE REPORT IS WRITTEN IN FRENCH AND ONLY ROUGHLY TRANSLATED IN HOUSE) IT IS WRITTEN IN THE REPORT, THAT THE PATIENT WAS IMPLANTED 20 YEARS AGO WITH A FEMORAL NAIL IMPLANT AND IT WAS VERY DIFFICULT TO REMOVE IT; SEVERAL OSTEOTOMIES OF THE FEMUR WERE PERFORMED. PATIENT STICKERS STATES THAT THE PATIENT WAS IMPLANTED WITH A DUROM CUP, METASUL LDH, HEAD ADAPATER, REVITAN STEM, BONE GRAFT AND CABLES. SURGICAL REPORT, DATE OF THE SURGERY: FEBRUARY 27, 2012 (THE REPORT IS WRITTEN IN FRENCH AND ONLY ROUGHLY TRANSLATED IN HOUSE) IT IS WRITTEN IN THE REPORT, THAT THE PATIENT WAS REVISED DUE TO METALLOSIS. THERE WERE NO SIGNS OF INFECTION AT THIS TIME. IT IS ALSO STATED THAT BONE GRAFT WAS USED AGAIN DUE TO OSTEOLYSIS. THE REVITAN STEM STAYED IN SITU; IN THIS SURGERY A CERAMIC HEAD 36 FROM ZIMMER WAS IMPLANTED. PATIENT STICKERS STATES THAT THE PATIENT WAS IMPLANTED WITH A SHELL, LINER (BOTH ZIMMER INC, WARSAW DESIGN) AND CERAMIC HEAD (ZIMMER GMBH, WINTERTHUR DESIGN). IN THE HOSPITAL REPORT, DATED MARCH 16, 2012, IT IS STATED THAT A PICC LINE WAS LAID WITHOUT COMPLICATION. THE REASON FOR INDICATION IS NOT STATED ON THE REPORT MEDICAL RECORDS (HANDWRITTEN IN FRENCH) DATED MARCH 20, 2012: INFECTION THP, 3 WEEKS POST OPERATION MEDICAL RECORDS (HANDWRITTEN IN FRENCH) DATED JULY 4, 2012: DIAGNOSIS: INFECTION OF THP TREATMENT: LARGE DEBRIDEMENT (HOWEVER, THIS CANNOT BE CONFIRMED SINCE THE HANDWRITING IS NOT CLEARLY READABLE) MEDICAL RECORDS (HANDWRITTEN IN FRENCH) DATED AUGUST 3, 2012 AND AUGUST 9, 2012: REMOVAL OF THE IMPLANTS DUE TO DEEP INFECTION WITH IMPLANTATION OF A PROSTALAC STEM. SURGICAL REPORT, DATE OF THE SURGERY: NOVEMBER 5, 2012 (THE REPORT IS WRITTEN IN FRENCH AND ONLY ROUGHLY TRANSLATED IN HOUSE) THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO BE IMPLANTED AGAIN WITH THP. 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 WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING RMW # 390679, REV 0 (FOR THE CERAMIC HEAD): - NON-STERILE DEVICE IS IMPLANTED DUE TO STERILIZATION PROCESS FAILURE => NOT POSSIBLE -> STERILIZATION SPECIFICATION OF THE DEVICE CERTIFIES THE SUITABILITY OF STERILIZATION. THE STERILIZATION CERTIFICATE OF THE AFFECTED LOT HAS BEEN REVIEWED AND WAS FOUND TO BE ACCORDING TO SPECIFICATION. - NON-STERILE DEVICE IS IMPLANTED DUE TO CONTAMINATED DEVICE DUE TO PACKAGING FAILURE => NOT POSSIBLE -> A SYSTEMATIC PACKAGING ISSUE HWOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - NON-STERILE DEVICE IS IMPLANTED DUE TO SURGEON RESTERILIZES HEAD AND/OR ADAPTER => NOT POSSIBLE -> THE SURGICAL REPORT DOES NOT DESCRIBE THAT THE HEAD AND/OR ADAPTER WERE RESTERILIZED. THEREFORE THIS CAUSE CAN BE EXCLUDED. - NON-STERILE DEVICE IS IMPLANTED, CROSS CONTAMINATION DUE TO EXPLANTED CERAMIC HEAD AND/OR ADAPTER IS REUSED WITH THE SAME OR NEW FEMORAL STEM => NOT POSSIBLE -> THE PATIENT WAS PRIMARLY IMPLANTED WITH A DUROM HEAD. THEREFOR THIS CAUSE CAN BE EXCLUDED. - NON-STERILE DEVICE IS IMPLANTED DUE TO PACKAGING IS DAMAGED DUE TO INADEQUATE HANDLING DURING TRANSPORTATION, STORAGE => POSSIBLE, APPROPRIATE HANDLING OR STORAGE OF THE DEVICE IT IS OUT OF ZIMMER 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 AND/OR ADAPTER) => NOT POSSIBLE -> A SYSTEMATIC LABELING ISSUE HWOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT DEFINED IN COMPLAINT INVESTIGATION WT-WI 295785 OR IN THE CURRENT PMS PROCESS CP12100 POST MARKET SURVEILLANCE. IN ADDITION, NOTHING WAS REPORTED BY THE COMPLAINANT ABOUT LABELING ISSUE. THEREFORE THIS CAUSE CAN BE EXCLUDED. ROOT CAUSE DETERMINATION USING RMW (FOR THE REVITAN STEM): - NON-STERILE DEVICE IS IMPLANTED DUE TO CLEANING PROCESS FAILURE => NOT POSSIBLE -> STERILIZATION SPECIFICATION OF THE DEVICE CERTIFIES THE SUITABILITY OF STERILIZATION. THE STERILIZATION CERTIFICATE OF THE AFFECTED LOT HAS BEEN REVIEWED AND WAS FOUND TO BE ACCORDING TO SPECIFICATION. - NON-STERILE DEVICE IS IMPLANTED DUE TO STERILIZATION PROCESS FAILURE => NOT POSSIBLE -> STERILIZATION SPECIFICATION OF THE DEVICE CERTIFIES THE SUITABILITY OF STERILIZATION. THE STERILIZATION CERTIFICATE OF THE AFFECTED LOT HAS BEEN REVIEWED AND WAS FOUND TO BE ACCORDING TO SPECIFICATION. - NON-STERILE DEVICE IS IMPLANTED DUE TO CONTAMINATED DEVICE DUE TO PACKAGING FAILURE => NOT POSSIBLE -> A SYSTEMATIC PACKAGING ISSUE HWOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - NON-STERILE DEVICE IS IMPLANTED DUE TO PACKAGING IS DAMAGED DUE TO INADEQUATE HANDLING DURING TRANSPORTATION, STORAGE => POSSIBLE, APPROPRIATE HANDLING AND/OR STORAGE OF THE DEVICE IT IS OUT OF ZIMMER CONTROL. THEREFORE THIS CAUSE CANNOT BE EXCLUDED. - NON-STERILE DEVICE IS IMPLANTED DUE TO THE USER IS USING AN INADEQUATE RE-STERILIZATION PROCEDURE => NOT POSSIBLE -> THE SURGICAL REPORT DOES NOT DESCRIBE THAT THE DEVICE WAS RESTERILIZED. THEREFORE THIS CAUSE CAN BE EXCLUDED. - NON-STERILE DEVICE IS IMPLANTED DUE TO IMPLANT IS FALLING ON THE FLOOR DURING HANDLING IN OR. => NOT POSSIBLE -> THE SURGICAL REPORT DOES NOT DESCRIBE SUCH A HANDLING ISSUE DURING THE SURGERY. THEREFORE THIS CAUSE CAN BE EXCLUDED. - NON-STERILE DEVICE IS IMPLANTED DUE TO EXPLANTED IMPLANT IS USED FOR NEW IMPLANTATION SURGERY => NOT POSSIBLE -> NOTHING IN THE INFORMATION RECEIVED (E.G. SURGICAL REPORT) POINTS TO THAT POSSIBILITY; IT IS NOT LIKELY THAT THE DEVICE WAS REUSED. THEREFORE THIS CAUSE CAN BE EXCLUDED. CONCLUSION SUMMARY: IT IS REPORTED THAT A PATIENT EXPERIENED A DEEP INFECTION AND UNDERWENT THEREFORE A REVISION SURGERY. THE GAMMA STERILIZATION SPECIFICATION OF THE DEVICES 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 THIS PRODUCT. IT IS HIGHLY UNLIKELY THAT A DISADVANTAGEOUS PRODUCT DESIGN FAVORED OR CONTRIBUTED TO THE 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. NEVERTHELESS, POSSIBLE CAUSES OF INFECTION INCLUDE WRONG HANDLING OF DEVICE DURING SURGERY, DURING TRANSPORTATION AND DURING STORAGE. HOWEVER, 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).
THE MANUFACTURER RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. 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. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
A PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A BIOLOX OPTION, HEAD, M,36/0, TAPER 12/14 ON THE RIGHT SIDE ON (B)(6) 2012 AND THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2012 DUE TO INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 915502 | BIOLOX OPTION, HEAD, M,36/0, TAPER 12/14 | BIOLOX OPTION HEAD | LZO | ZIMMER GMBH | N/A | 2453225 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Hospitalization| R |