REVITAN DISTAL PART STRAIGHT, UNCEMENTED, 18/200
Report
- Report Number
- 0009613350-2018-01113
- Event Type
- Injury
- Date Received
- October 31, 2018
- Date of Event
- June 26, 2018
- Report Date
- May 28, 2019
- Manufacturer
- ZIMMER GMBH
- Product Code
- JDI
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
ADDITIONAL INFORMATION WAS RECEIVED. REVITAN PROXIMAL PART, CONICAL, UNCEMENTED, 55, TAPER 12/14, REF: (B)(4), LOT: 2830281 SULOX HEAD, L, 28/+3.5, TAPER 12/14, REF:17.28.07, LOT:2810692 CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH, REF:(B)(4), LOT:00223200418 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).
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: BREAKAGE. EVENT SUMMARY: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH REVITAN STEM ON (B)(6) 2016. PATIENT UNDERWENT REVISION FOR REVITAN STEM ON (B)(6) 2018 DUE TO IMPLANT FRACTURE. FOLLOWING DOCUMENTATION WAS RECEIVED AND REVIEWED: X-RAYS TAKEN BEFORE, DURING AND AFTER THE TIME IN VIVO OF THE REVITAN STEM. IMPLANTATION REPORT OF (B)(6) 2016. PATIENT RECORD FORM FOR THE INTERVENTION ON (B)(6) 2016. REVISION REPORT OF (B)(6) 2018. ANSM REPORT: THE HOSPITAL REPORTED THE CASE TO THE COMPETENT AUTHORITY. DEVICES ANALYSIS VISUAL EXAMINATION: THE CONNECTION PIN OF THE REVITAN STEM IS FRACTURED IN THE NON-BLASTED AREA. THE FRACTURE IS LOCATED APPROXIMATELY 1 TO 2 MM BELOW THE PROXIMALEND OF THE DISTAL PART. THE PROXIMAL PART OF THE CONNECTION PIN IS STILL ASSEMBLED TO THE PROXIMAL PART OF THE REVITAN STEM. THE FRACTURE SURFACES SHOW A FATIGUE FRACTURE STARTING FROM THE LATERAL SIDE. THE MEDIAL END OF THE PROXIMAL FRACTURE SURFACE IS POLISHED TO A SHINE. THE EDGES OF THE PROXIMAL FRACTURE SURFACE ARE PARTIALLY POLISHED AND DEFORMED. BOTH FRACTURE SURFACES SHOW SOME SCRATCHES. IN ADDITION, ON THE DISTAL FRACTURE SURFACE A DRILL MARK CAN BE OBSERVED. MACROSCOPICALLY, AS FAR AS VISIBLE, NO DEFECTS THAT COULD HAVE TRIGGERED OR FAVORED THE FRACTURE WERE FOUND ON THE FRACTURE SURFACES. ON THE PROXIMAL PART OF THE REVITAN STEM SEVERAL SCRATCHES AND NICKS CAN BE OBSERVED. THESE DERIVED MOST PROBABLY FROM THE REVISION SURGERY. ON THE ANCHORING SURFACE OF THE PROXIMAL STEM PART THERE ARE NO SIGNS OF BONE ONGROWTH. ON THE LATERAL AND ANTERIOR SIDE OF THE ANCHORING SURFACE AS WELL AS ON THE ANTEROLATERAL SIDE OF THE STEM NECK THERE ARE SEVERAL COLORED SPOTS, RANGING FROM BROWN TO DARK BLUE TO DARK GREY. ON THE PROXIMAL FRACTURE PART OF THE CONNECTION PIN THERE IS A HALF CIRCUMFERENTIAL STRIPE REVEALING SURFACE CHANGES ADJACENT TO THE FRACTURE SURFACE. CLOSER INSPECTION OF THE STRIPE WITH A LOW POWER MICROSCOPE REVEALED SMEARED METAL AND SIGNS OF FRETTING AND CORROSION. ADJACENT TO THE STRIPE JOINS THE ORIGINAL SURFACE FOLLOWED BY THE BLASTED AREA. ON THE BLASTED SURFACE OF THE PIN AREAS WITH SMEARING CAN BE NOTICED ON THE ANTERIOR AND POSTERIOR SIDES. ON THE DISTAL HALF OF THE DISTAL PART OF THE REVITAN STEM BONE ATTACHMENTS ARE VISIBLE ON THE ANCHORING SURFACE. THE LATTER ALSO SHOWS REMOVAL DAMAGE IN THE FORM OF SCRATCHES, NICKS AND DRILL MARKS. THE DISTAL TIP OF THE STEM SHOWS DAMAGE FROM REMOVAL AS WELL. ON THE ANTEROLATERAL AND MEDIAL SIDE OF THE FACE SURFACE AS WELL AS ON THE ANTEROLATERAL EDGE OF THE POSTERIOR NOSE THERE ARE SEVERAL AREAS WITH DAMAGE. THE LATERAL AND POSTEROLATERAL EDGE OF THE ANTERIOR NOSE IS SLIGHTLY POLISHED. ON THE FACE SURFACE OF THE ANTERIOR NOSE A BLACK SPOT CAN BE OBSERVED. THE SULOX HEAD WAS RECEIVED COMBINED WITH A SATURNE DUAL MOBILITY INSERT. THE POLYETHYLENE INSERT IS SLIGHTLY DEFORMED TO AN OVAL, PROBABLY AS A RESULT OF HEAT EXPOSURE DURING STERILIZATION OF THE EXPLANTS IN THE CLINIC AFTER REVISION. SLIGHT METALLIC SMEARING CAN BE NOTICED ON THE BOTTOM BEVEL OF THE HEAD. THIS DERIVED PROBABLY FROM THE REVISION SURGERY. THE HEAD TAPER SHOWS THE COMMONLY OBSERVED METAL TRANSFER FROM THE STEM TAPER INDICATING A PROPER FIXATION OF THE HEAD ON THE STEM AND THE MATERIAL TRACK PROBABLY FROM ITS REMOVAL. THE GREATER TROCHANTER REATTACHMENT PLATE HAS FOUR CERCLAGE WIRE SEGMENTS ATTACHED. THE WIRES SEEM TO BE CUT, MOST PROBABLY DURING REVISION SURGERY. FOR EACH WIRE, ONE END IS FIXED WITH A SET SCREW WHILE THE OTHER END IS FIXED VIA THE PLUG COUNTER SUNK. ON THE NON-BONE FACING SIDE OF THE PLATE AND ON THE WIRES THERE ARE SEVERAL COLORED SPOTS, SIMILAR TO THE ONES OBSERVED ON THE PROXIMAL PART OF THE REVITAN STEM. REVIEW OF PRODUCT DOCUMENTATION: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS NOT APPROVED BY ZIMMER BIOMET. CONCLUSION SUMMARY: THE REVITAN STEM WAS REVISED AFTER 1 YEAR AND 9 MONTHS IN VIVO BECAUSE OF ITS FRACTURE. THE LATTER OCCURRED DUE TO FATIGUE IN THE NON-BLASTED AREA OF THE CONNECTION PIN SOME MILLIMETRES BELOW THE PROXIMAL END OF THE DISTAL PART. THE FRACTURE STARTED ON THE LATERAL SIDE OF THE PIN. MACROSCOPICALLY, AS FAR AS VISIBLE, NO DEFECTS THAT COULD HAVE TRIGGERED OR FAVORED THE FRACTURE COULD BE FOUND ON THE FRACTURE SURFACES. ON THE PROXIMAL FRACTURE PART OF THE PIN THERE IS A HALF CIRCUMFERENTIAL STRIPE REVEALING A MIXTURE OF SURFACE CHANGES. IT IS UNKNOWN IF THESE SURFACE CHANGES EXISTED ALREADY BEFORE THE START OF THE FRACTURE OR DEVELOPED EXCLUSIVELY AS A CONCOMITANT PHENOMENON. ACCORDING TO THE RECEIVED DOCUMENTATION, ON (B)(6) 2016 THE PATIENT HAD A REVISION OF A RIGHT HIP PROSTHESIS DUE TO INFECTION. DURING THIS SURGERY AN ANTERIOR FEMORAL FLAP WAS MADE AND A FRACTURE OF A LATERAL CORTICAL FRAGMENT TEARING OFF MOST OF THE TROCHANTER MAJOR OCCURRED. AN AMPLITUDE OPTIMA STEM WAS IMPLANTED WITH THREE CERCLAGES. APPROXIMATELY 2 MONTHS LATER, DUE TO A DISASSEMBLY OF THE MODULAR NECK AND SUBSIDENCE OF THE OPTIMA STEM A REVISION WAS PERFORMED AND A REVITAN STEM WAS IMPLANTED. THE IMPLANTATION REPORT OF THE REVITAN STEM STATES THAT AFTER THE FINAL PROSTHESIS WAS IMPACTED AN EXCELLENT STABILITY WAS ACHIEVED DESPITE A DISTAL DIAPHYSEAL FISSURE FOUND BEFORE THE PREPARATION OF THE FEMUR. TWO CERCLAGES WERE PLACED AROUND THE DISTAL FEMUR TO STOP THE FISSURE. THEN THE LATERAL CORTICAL FRAGMENT WITH THE TROCHANTER MAJOR WAS REDUCED, THE ANTERIOR FEMORAL FLAP WAS REPOSITIONED AND A TROCHANTERIC PLATE WITH FOUR CABLES WAS IMPLANTED FOR STABILIZATION. THE SURGICAL REPORT STATES THAT THERE WAS STILL A MODERATE LOSS OF BONE SUBSTANCE BETWEEN THE FRAGMENTS. THIS COMPLICATED, INSTABLE SITUATION IS REFLECTED ALSO IN THE X-RAYS TAKEN IMMEDIATELY AFTER THE IMPLANTATION OF THE REVITAN STEM AND IN THE SUBSEQUENT TWO WEEKS AND TWO MONTHS FOLLOW-UPS. THE REVISION REPORT OF (B)(6) 2018 CONFIRMS THE CONSOLIDATION OF THE FEMORAL FLAP AND OF THE FRACTURE OF THE TROCHANTER MAJOR. IT IS MENTIONED THAT THE PROXIMAL FRACTURE PART OF THE REVITAN STEM AND THE DUAL MOBILITY INSERT ARE REMOVED WITHOUT MAJOR DIFFICULTY. AS THE STEM¿S DISTAL PART WAS PERFECTLY INTEGRATED INTO THE FEMUR SEVERAL ATTEMPTS TO REMOVE IT WERE NEEDED. THE X-RAYS TAKEN JUST BEFORE REVISION OF THE REVITAN STEM POINT TO THE CONSOLIDATION OF THE FEMORAL FLAP AND THE FRACTURE OF THE TROCHANTER MAJOR. HOWEVER, RADIOLUCENT AREAS ARE VISIBLE ON THE MEDIAL AND POSTEROMEDIAL SIDE OF THE PROXIMAL STEM PART WHICH EXTEND TO THE PROXIMAL REGION OF THE DISTAL STEM PART. RADIOLUCENCY BETWEEN THE TROCHANTERIC PLATE AND THE LATERAL SIDE OF THE STEM IS VISIBLE AS WELL. THESE POINTS TO AN INSTABLE SITUATION ON THE LATERAL, MEDIAL AND POSTEROMEDIAL SIDE OF THE STEM. ON THE ANCHORING SURFACE OF THE RETRIEVED REVITAN STEM BONE ATTACHMENTS ARE ONLY VISIBLE IN THE DISTAL HALF OF THE DISTAL PART BUT NOT IN THE PROXIMAL HALF OF THE DISTAL STEM PART AND ON THE PROXIMAL STEM PART. THIS MIRRORS THE SITUATION SEEN ON THE X-RAYS AT HAND AND THE DESCRIPTION IN THE REVISION REPORT. BASED ON THE ABOVE DESCRIBED FINDINGS, THE PROXIMAL BONE SUPPORT OF THE REVITAN STEM IMMEDIATELY AFTER IMPLANTATION AND POSSIBLY THROUGHOUT THE ENTIRE TIME IN VIVO CAN BE INTERPRETED AS INSUFFICIENT. THUS, IT CAN BE HYPOTHESIZED THAT THE INSUFFICIENT PROXIMAL BONE SUPPORT, ESPECIALLY ON THE MEDIAL SIDE, IN COMBINATION WITH OTHER FACTORS, E.G. THE SURFACE CHANGES OBSERVED ON THE CONNECTION PIN AND THE PATIENT¿S OBESITY (AS REPORTED IN THE IMPLANTATION REPORT) MAY HAVE CONTRIBUTED TO THE FRACTURE. IT IS UNKNOWN TO WHICH EXTENT EACH FACTOR HAD AN INFLUENCE ON THE SEQUENCE OF EVENTS AND IF THERE WERE OTHER INFLUENCING FACTORS. THE REVITAN REVISION STEM SYSTEM PACKAGE INSERT THAT ACCOMPANIED THE PROXIMAL PART OF THE REVITAN STEM ESPECIALLY POINTS TO THESE FACTS UNDER THE WARNINGS SECTION: HEAVY PATIENTS WHO ENGAGE IN HIGH LEVELS OF PHYSICAL ACTIVITY AND WHO DO NOT HAVE PROXIMAL BONE SUPPORT, ESPECIALLY MEDIALLY, ARE SUBJECT TO A RISK OF IMPLANT FAILURE WHEN A MODULAR REVISION STEM IS USED. IN SUCH CASES THE SURGEON SHOULD CONSIDER SURGICAL OPTIONS TO ENSURE PROXIMAL BONE SUPPORT OR SWITCHING TO A MONOBLOC REVISION STEM. THE COLORED SPOTS OBSERVED ON THE PROXIMAL PART OF THE REVITAN STEM AND ON THE GREATER TROCHANTERIC REATTACHMENT DEVICE CAN MOST PROBABLY BE ATTRIBUTED TO THE USE OF AN ELECTROCAUTERY INSTRUMENT DURING SURGERY. THE SULOX HEAD WAS USED IN COMBINATION WITH A DUAL MOBILITY INSERT FROM ANOTHER MANUFACTURER. THIS IS AN UNAUTHORIZED COMBINATION AND HAS TO BE CONSIDERED OFF-LABEL USE. 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).
NO EVENT UPDATE.
NO CHANGE TO PREVIOUSLY REPORTED EVENT.
THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K0171323 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).
PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT REVISION SURGERY DUE TO IMPANT FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 863926 | REVITAN DISTAL PART STRAIGHT, UNCEMENTED, 18/200 | REVITAN DISTAL PART | JDI | ZIMMER GMBH | N/A | 2782383 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |