BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14
Report
- Report Number
- 0009613350-2017-01806
- Event Type
- Injury
- Date Received
- December 20, 2017
- Date of Event
- March 26, 2015
- Report Date
- July 5, 2018
- Manufacturer
- ZIMMER GMBH
- Product Code
- LZO
- PMA / PMN Number
- PK071535
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: INFECTION. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A CERAMIC HEAD AND HAD AROUND 1 YEAR POST IMPLANTATION A SURGERY FOR IRRIGATION AND DEBRIDEMENT DUE TO SWELLING AND A SMALL LUMP OF HIS HIP. THIS IS A SPLIT CASE, FOR DEVICES MANUFACTURED BY ZIMMER INC., WARSAW SEE (B)(4)) . THE PATIENT HAD LONG HISTORY OF PAIN AND UNDERWENT RIGHT TOTAL THA; PATIENT EXPERIENCED 3 DISLOCATION AND WAS SUBSEQUENTLY REVISED; AFTERWARDS THE PATIENT EXPERIENCED INFECTION OF THIS HIP AND WAS REVISED AGAIN . MEDICAL HISTORY WITH HIS RIGHT HIP: 3.5 MONTHS POST IMPLANTATION DISLOCATION WITH CLOSED REDUCTION (THIS CASE IS FILED UNDER (B)(4) AND FOR DEVICES MANUFACTURED BY ZIMMER INC., WARSAW SEE (B)(4)). SECOND DISLOCATION 1 YEAR POST IMPLANTATION (THIS CASE IS FILED UNDER (B)(4) AND FOR DEVICES MANUFACTURED BY ZIMMER INC., WARSAW SEE (B)(4)). REVISION SURGERY AFTER THIRD DISLOCATION (THIS CASE IS FILED UNDER (B)(4) AND FOR DEVICES MANUFACTURED BY ZIMMER INC., WARSAW SEE (B)(4)) 13 DAYS POST IMPLANTATION THE PATIENT WAS REVISED AGAIN DUE TO INFECTION (THIS CASE IS FILED UNDER (B)(4) AND FOR DEVICES MANUFACTURED BY ZIMMER INC., WARSAW SEE (B)(4)). REVIEW OF RECEIVED DATA ONLY THE REPORTS RELATED TO PATIENT CURRENT AND PREVIOUSLY INFECTIONS ARE SUMMARIZED HERE. SURGICAL REPORT, DATED ON (B)(6) 2014 (THIS EVENT IS TREATED IN (B)(4), RESPECTIVELY (B)(4) -FOR DEVICES MANUFACTURED BY ZIMMER INC., WARSAW) PREOPERATIVE DIAGNOSIS: DRAINING HEMATOMA, STATUS POST REVISION RIGHT TOTAL HIP. PROCEDURE: DEEP IRRIGATION AND DEBRIDEMENT WITH EVACUATION OF HEMATOMA AND EXCHANGE OF THE ACETABULAR POLYETHYLENE LINER AND THE FEMORAL HEAD, RIGHT TOTAL HIP. INDICATIONS: THE OPERATIVE REPORT STATES THAT WHEN PATIENT WAS DISCARDED 3 DAYS POST IMPLANTATION HE WAS DOING FINE. A FEW DAYS LATER, HE BEGAN TO HAVE BLOODY DRAINAGE FROM THE INFERIOR ASPECT OF HIS WOUND. IT WAS CLEAR THAT HE HAD A DRAINING HEMATOME. AS PATIENT IS HIV-POSITIVE IT WAS ELECTED TO TREAT HIM AGGRESSIVELY AS THE DOCTOR FELT THIS WAS A DRAINING HEMATOMA WITH POTENTIAL FOR DEVELOPING INFECTION. EXTENSIVE IRRIGATION AND DEBRIDEMENT WITH EXCHANGE OF THE FEMORAL HEAD AND THE ACETABULAR LINER WILL BE PERFORMED. DESCRIPTION OF PROCEDURE: THE OPERATIVE REPORT STATES THAT THE OLD INCISION WAS REOPENED, AND SIMPLY BY CUTTING THE SUTURES. IT WAS REALLY NOT NEEDED TO DO ANY FURTHER INCISION OF TISSUE. A LARGE CLEAN-APPEARING HEMATOMA WAS ENCOUNTERED. AN EXTENSIVE IRRIGATION AND DEBRIDEMENT AND EVACUATION OT THIS HEMATOMA WAS DONE. ALL QUESTIONABLE OR NECROTIC-APPEARING MATERIAL WAS EXCISED. THE FEMORAL HEAD AND THE LINER WERE REMOVED. A NEW CONSTRAINED PE LINER AND CERAMIC HEAD WERE IMPLANTED. 2 SINGLE MEDIUM DRAINS DEEP IN THE WOUND WERE PLACED. DOCTOR REPORT, DATED ON (B)(6) 2014 HISTORY OF PRESENT ILLNESS: PATIENT IS A MONTH OUT FROM REVISION DONE FOR RECURRENT DISLOCATIONS. ABOUT A WEEK LATER, HE PRESENTED WITH DRAINING HEMATOMA. THE HEMATOMA WAS WASHED OUT DURING A SURGERY. INTRAOPERATIVE CULTURES GREW COAG-NEGATIVE STAPH, SENSITIVE BASICALLY TO EVERYTHING. PATIENT IS ON DAPTOMYCIN AND IS DOING FINE AND FEELING BETTER ALL THE TIME. PHYSICAL EXAMINATION: THE WOUND IS CLEAN, DRY AND HEALING NICELY. THERE IS NO DRAINAGE. DOCTOR REPORT, DATED ON (B)(6) 2015 THE REPORT STATES THAT PATIENT COMPLETED 6-WEEK COURSE OF IV DAPTOMYCIN AFTERWARDS THE REVISION SURGERY OF (B)(6) 2014. THROUGHOUT THIS TIME, HE WAS CONTINUING APPARENTLY TO COMPLAIN OF PAIN IN HIS HIP. HE HAD SOME PHYSICAL THERAPY. AROUND 3 MONTHS AGO (END OF 2014) HE HAD SWELLING AND SMALL LUMP ALONG HIS HIP NOTICED. ON (B)(6) 2015 A LITTLE IRRIGATION AND DEBRIDEMENT WAS DONE. CULTURES WERE TAKEN AND THEY GROWING COAG-NEGATIVE STAPH. HIS C-REACTIVE PROTEIN WAS 4.6 (UPPER LIMIT OF NORMAL 0.9). PATIENT SAYS THAT HE HAS FEELING BETTER SINCE THE PROCEDURE AND THAT MOST OF THE ERYTHEMA IS GONE BUT HE STILL BEEN DRAINING FAIR AMOUNT AND HAVING TO CHANGE THE DRESSINGS. HE IS WALKING WITH A LIMP. THE RADIOGRAPH FINDINGS STATES THAT HE DOES HAVE SOME RADIOLUCENCIES, ESPECIALLY AROUND THE PROXIMAL FEMUR, WHICH COULD BE CONSISTENT WITH A CHRONICALLY INFECTED HIP. HOWEVER, THE STEM DOES APPEAR TO PROBABLY BE STABLE. IMPRESSIONS: PROBABLE CHRONICALLY INFECTED RIGHT TOTAL HIP IN A PATIENT WITH HIV DISEASE. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. ACCORDING TO THE INFORMATION RECEIVED, THE PRODUCT LOCATION IS UNKNOWN. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING RMW: NON-STERILE DEVICE IS IMPLANTED DUE TO STERILIZATION PROCESS FAILURE NOT POSSIBLE , THE STERILIZATION METHOD IS VALIDATED ACCORDING TO THE STERILIZATION SPECIFICATION. NON-STERILE DEVICE IS IMPLANTED DUE TO CONTAMINATED DEVICE DUE TO PACKAGING FAILURE 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. NON-STERILE DEVICE IS IMPLANTED DUE TO SURGEON RESTERILIZES HEAD 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. NON-STERILE DEVICE IS IMPLANTED DUE TO PACKAGING IS DAMAGED DUE TO INADEQUATE HANDLING DURING TRANSPORTATION, STORAGE POSSIBLE, THE HANDLING OF THE DEVICE IS OUT OF ZIMMER BIOMET CONTROL. NON-STERILE DEVICE IS IMPLANTED, CROSS CONTAMINATION DUE TO EXPLANTED CERAMIC HEAD IS REUSED WITH THE SAME OR NEW FEMORAL STEM 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. 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) POSSIBLE, (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: A PATIENT WAS IMPLANTED WITH A CERAMIC HEAD AND HAD AROUND 1 YEAR POST IMPLANTATION A SURGERY FOR IRRIGATION AND DEBRIDEMENT DUE TO SWELLING AND A SMALL LUMP OF HIS HIP. 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. 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 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).
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. (B)(4).
IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14 ON THE RIGHT SIDE ON (B)(6) 2014. BEGINNING OF 2015 PATIENT COMPLAIN OF PAIN IN HIS HIP. ON (B)(6) 2015, THE PATIENT WENT TO HOSPITAL IN FOR AN IRRIGATION AND DEBRIDEMENT PROCEDURE. INFO FROM THE MEDICAL RECORDS OF (B)(6) ORTHOPEDIC INSTITUTE:: PATIENT IS WALKING WITH A LIMP. PURULENT MATERIAL IS DRAINING FROM THE WOUND. DIAGNOSE: PROBABLE CHRONICALLY INFECTED RIGHT HIP IN A PATIENT WITH (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 914734 | BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14 | BIOLOX DELTA CERAMIC FEMORAL HEAD | LZO | ZIMMER GMBH | N/A | 2719379 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Hospitalization| R |