BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 32/0, TAPER 12/14
Report
- Report Number
- 0009613350-2017-01560
- Event Type
- Injury
- Date Received
- November 14, 2017
- Date of Event
- March 31, 2017
- Report Date
- April 30, 2018
- Manufacturer
- ZIMMER GMBH
- Product Code
- LZO
- PMA / PMN Number
- P071535
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
CONCOMITANT MEDICAL PRODUCTS: REF# (B)(4), LOT# 63186933, NAME: LINER STANDARD 32 MM I.D. FOR USE WITH 50/52/54 MM O.D. SHELLS REF# (B)(4), LOT# 63151209, NAME: MODULAR NECK B 12/14 NECK TAPER USE WITH +0 HEADS ONLY REF#(B)(4), LOT# 60981742, NAME: SHELL POROUS WITH CLUSTER HOLES 50 MM O.D. 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 71 YEARS OLD FEMAL PATIENT WITH A BILATERAL TOTAL HIP REPLACEMENTS UNDEWERNT A REVISION SURGERY DUE TO SUSEPCTED INFECTION. REVIEW OF RECEIVED DATA: THE FOLLOWING, CASE RELEVANT MEDICAL RECORDS WERE REVIEWED: SURGICAL REPORT OF IMPLANTATION DATED (B)(6) 2016 (THIS SURGERY IS A REVISION SURGERY REFLECTED IN (B)(4) CASE FROM ZIMMER INC, WARSAW, MFR 0001822565-2017-07674) SURGICAL INTERVENTION FOR POSSIBLE HEMATOMA WITH POSSIBLE INFECTION DATED MARCH 26, 2016 CASE (B)(4) (MFR 0009613350-2017-01546) AND (B)(4) (ZIMMER WARSAWINC, SPLIT CASE, MFR 0001822565-2017-07677). SURGICAL REPORT OF REVISION PROCEDURE DATED (B)(6) 2017 CASE AT HAND AND (B)(4). SURGICAL REPORT OF IMPLANTATION DATED (B)(6) 2016: PRE- AND POSTOPERATIVE DIAGNOSIS: FAILED RIGHT TOTAL HIP ARTHROPLASTY SECONDARY TO POLYETHYLENE WEAR AND SUBSEQUENT OSTEOLYSIS. PROCEDURE PERFORMED: REVISION RIGHT THA WITH POLYETHYLENE EXCHANGE AND PLACEMENT OF A NEW FEMORAL HEAD. THE DESCRIPTION OF THE PROCEDURE MENTIONED IN THIS SURGICAL REPORT IS FOR LEFT HIP. ONLY THE PREOPERATIVE/POSTOPERATIVE DIAGNOSIS AND INDICATIONS FOR PROCEDURE SECTIONS BELONGS TO THE RIGHT HIP. THOUGH SURGEON MENTIONED IN THE OP NOTES THAT IT WAS DICTATED INCORRECTLY AND WILL BE REPLACED TO RIGHT HIP, DESCRIPTION OF PROCEDURE WAS NOT UPDATED. SURGICAL INTERVENTION DATED MARCH 26, 2016:(B)(4) AND (B)(4) ZIMMER INC., WARSAW SPLIT CASE) PREOPERATIVE DIAGNOSIS: POSSIBLE HEMATOMA ABOUT RIGHT TOTAL HIP INCISION. POSTOPERATIVE DIAGNOSIS: HEMATOA WITH PROBABLE INFECTION, FOLLOWING RIGHT THA, SUPERFICIAL. PROCEDURE PERFORMED: IRRIGATION AND DEBRIDEMENT OF THE SOFT TISSUE ABOUT THE RIGHT TOTAL HIP WOUND. THE REPORTS ALSO SAYS: "WHERE IN EARLY FEBRUARY SHE UNDERWENT A REVISION OF THE HIP WHICH WAS PERFORMED WHERE THE HEAD WAS IDENTIFIED TO HAVE A LEVEL OF TRUNNIONOSIS AT THE TRUNNION HEAD JUNCTION. THERE WAS ALSO EVIDENCE OF SOME GRAYISH FLUID, AND AT THAT TIME THE DIAGNOSIS OF TRUNNIONOSIS WAS FELT TO BE CONSISTENT. THERE WAS NO EVIDENCE OF GROSSPURULENCE. THE PATIENT AT THIS POINT IN TIME CLEARLY HAS AN INFECTIOUS PROCESS. ¿ SHE AT THIS POINT WILL PROCEED ON IV ANTIBIOTICS. SURGICAL REPORT OF REVISION DATED (B)(6) 2017: PERFORMED PROCEDURE: INFECTED RIGHT THA HOSPITAL COURSE: THE PATIENT WAS BROUGHT INTO THE HOSPITAL INITIALLY UNDER OBSERVATION. SHE WAS TAKEN TO INTERVENTIONAL RADIOLOGY ON FIRST DAY FOR JOINT ASPIRATION. ON MARCH 31, 2017 PATIENT WAS TAKEN TO OR FOR RIGHT HIP I & D ALONG WITH REMOVAL OF THE ACETABULAR COMPONENT AS WELL AS NECK COMPONENT AND INSERTION OF AN ANTIBIOTIC- IMPREGNATED SPACER. THE ORIGINAL STEM WAS LEFT PLACE¿. THE REPORTS ALSO STATES: :CULTURES WERE FOLLOWED....DEVICE CULTURE HAS GROWN OUT GREATHER THAN 100CFU/ML OF CONCENTRATION SONICFLUID, MICROMONAS MICROS, AND ONE OF SEVERAL CULTURES OF THE DEEP WOUND GREW OUT SCANT GROWTH MICROMONAS MICROS .INTRAOPERATIVELY THERE WAS EVIDENCE OF LARGE PURULENT DEFECTS" DISCHARGE DIAGNOSIS: . RECURRENT RIGHT PROSTHETIC HIP INFECTION STATUS POST INCISION AND DEBRIDEMENT. ACUTE CHRONIC ANEMIA MANAGED WIHT 3 UNITS OF PACKED RED BLOOD CELLS. CHRONIC KIDNEY DISEASE. DIABETES MELLITUS. ANEXITY. DEMENTIA. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. ACCORDING TO THE AVAILABLE INFORMATION, THE PRODUCT LOCATION IS UNKNOWN, REVIEW OF PRODUCT DOCUMENTATIO:N THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. IFU FOR ENDOPROSTHESIS. STERILE CERTIFICATE. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING DFMEA: INCORRECT STERILIZATION METHOD LEADS TO NON STERILE HEAD IMPLANT DUE TO INCORRECT STERILIZATION METHOD. NOT POSSIBLE: GAMMA STERILIZATION SPECIFICATION OF THE DEVICE CERTIFIES THE SUITABILITY OF STERILIZATION. THE IRRADIATION CERTIFICATE OF THE AFFECTED LOT HAS BEEN REVIEWED AND WAS FOUND TO BE ACCORDING TO SPECIFICATION. NON STERILE PRODUCT DUE TO IMPROPER HANDLING DURING SURGERY DUE TO WRONG HANDLING OF DEVICE DUE TO WRONG INFORMATION POSSIBLE: SURGICAL TECHNIQUE AND IFUS ARE IN PLACE WHICH DESCRIBE THE PROPER HANDLING OF THE DEVICES. HOWEVER, SINCE ONLY INCOMPLETE SURGICAL REPORT RECEIVED, IT CANNOT BE EVALUATED IF THE PRODUCTS WERE HANDLED PROPERLY. TRANSMISSION OF INFECTIOUS AGENTS OR MECHANICAL FAILURE DUE TO REUSE OF THE DEVICE WHICH IS ONLY INTENDED FOR SINGLE USE. NOT POSSIBLE: ACCORDING TO THE INFORMATION RECEIVED IT IS NOT LIKELY THAT THE DEVICE WAS REUSED. CONCLUSION SUMMARY: A BILATERAL PATIENT WITH A HISTORY OF THA UNDERWENT A REVISION SURGERY 13 MONTHS POST IMPLANTATION DUE TO INFECTION. THE GAMMA STERILIZATION SPECIFICATION OF THE DEVICE CERTIFIES THE SUITABILITY OF STERILIZATION. THE IRRADIATION CERTIFICATE OF THE AFFECTED LOT HAS BEEN REVIEWED AND WAS 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 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 INFORMATION WAS RECEIVED ON DECEMBER 7, 2017. 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. (B)(4).
THE MANUFACTURER DID NOT 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).
IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 32/0, TAPER 12/14 ON THE RIGHT SIDE ON (B)(6) 2016 AND THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017 DUE TO INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 809568 | BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 32/0, TAPER 12/14 | BIOLOX DELTA CERAMIC FEMORAL HEAD | LZO | ZIMMER GMBH | N/A | 2796802 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Hospitalization| R |