REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 24/200
Report
- Report Number
- 0009613350-2018-00312
- Event Type
- Injury
- Date Received
- March 1, 2018
- Date of Event
- February 1, 2018
- Report Date
- June 11, 2018
- Manufacturer
- ZIMMER GMBH
- Product Code
- LZO
- PMA / PMN Number
- PN/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
ADDITIONAL: DEVICE AVAILABLE FOR EVALUATION. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: FRACTURE OF THE STEM. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. EVENT DESCRIPTION (EVENT DETAILS, PER). THE HIP PROSTHESIS WAS REVISED AFTER APPROXIMATELY 9 YEARS IN VIVO DUE TO A FRACTURE OF THE CONNECTION PIN OF THE REVITAN STEM. REVIEW OF RECEIVED DATA: PROVIDED EVENT INFORMATION. THE REPORTED EVENT WAS DESCRIBED AS FOLLOWS: ¿A PATIENT BORN (B)(6). VERY ACTIVE MAN. GOT A CEMENTED LINK PROTSHESIS (LUBINUS) IN HIS LEFT HIP 2007. THE STEM GOT LOOSE AND IT GET REVISED 2009 WITH A LONG REVITAN SIZE 24 MM X 200. THE CUP WAS NOT REVISED. NOW HAVE THE CONNECTION ,BETWEEN THE STEM AND THE PROXIMAL PART, FRACTURED. THE PATIENT IS NOW BEEN REVISED WITH AN ARCOS STEM 27 MM X 190 MM + 80 MM CONE BODY SIZE C WITH A LARGE TROCHANDER CLAW AND A CONTIUUM CUP WITH 36 MM HEAD. CERCLAGES AND SOME SCREWS.¿ NEITHER AN EXACT DATE OF IMPLANTATION NOR OF EXPLANTATION IS AT HAND. AS EVENT DATE (B)(6) 2018 IS INDICATED. X-RAYS: THERE ARE 6 AP X-RAYS AVAILABLE BETWEEN (B)(6) 2007 AND (B)(6) 2018. THE X-RAY DATED (B)(6) 2007 SHOWS THE LEFT HIP SIDE BEFORE IMPLANTATION OF A PROSTHESIS. IT SEEMS THAT THERE IS A FRACTURE OF THE FEMORAL NECK. ON THE X-RAY DATED (B)(6) 2007 A CEMENTED STEM AND A CEMENTED CUP ARE IMPLANTED ON THE LEFT HIP. THE X-RAY IS TAKEN SHORTLY AFTER IMPLANTATION AS THE STAPLES OF THE SKIN SUTURE ARE STILL IN PLACE. THE CEMENT MANTLE OF THE STEM DOES NOT HAVE A HOMOGENOUS THICKNESS. COMPARING THE X-RAY TAKEN ON (B)(6) 2008 WITH THE PREVIOUS X-RAY IT SEEMS THAT THE STEM IS SLIGHTLY SUBSIDED AND THERE IS A RADIOLUCENT LINE AT THE CEMENT-BONE INTERFACE. A SCLEROTIC LINE MARKING THE BORDER BETWEEN BONE AND CEMENT SEEMS TO BE VISIBLE ON THE MEDIAL SIDE IN THE TROCHANTER MINOR AREA. IN THIS AREA THE APPEARANCE OF THE CEMENT STRUCTURE SEEMS TO HAVE CHANGED. ON THE X-RAY DATED (B)(6) 2012 A REVITAN STEM IS IMPLANTED AND THE CUP IS THE SAME AS BEFORE. ON THE LATERAL SIDE A SCLEROTIC LINE IS OBVIOUS UNTIL THE HEIGHT OF THE STEM¿S JUNCTION BETWEEN ITS PROXIMAL AND THE DISTAL PART. HOWEVER, WITH HIGHER MAGNIFICATION IN THE JUNCTION AREA COMPARING THE IMAGE TO THE PREVIOUS ONE, IT COULD BE POSSIBLE THAT IN THE MEDULLARY CANAL THERE ARE SOME REMAINS OF BONE CEMENT HAVING THE SAME RADIO-OPAQUE APPEARANCE LIKE BONE AND THAT THE SCLEROTIC LINE COULD PROBABLY CONTINUE UNTIL THE DISTAL END OF THE TAPERED AREA OF THE STEM BODY. ON THE MEDIAL SIDE A SCLEROTIC LINE IS VISIBLE UNTIL A LITTLE BELOW THE DISTAL END OF THE TAPERED AREA OF THE STEM BODY. THERE IS A GAP BETWEEN THE SCLEROTIC LINE MARKING THE BONE¿S BORDER AND THE IMPLANT. THE X-RAY TAKEN ON (B)(6) 2017 HAS A HIGHER CONTRAST COMPARED TO THE PREVIOUS ONE SO THAT THE ALREADY DESCRIBED SCLEROTIC LINES AND THE GAP BETWEEN BONE AND IMPLANT ARE MORE CLEARLY VISIBLE (FIG. 4). FURTHER, IT SEEMS THAT THE PROXIMAL STEM PART IS SLIGHTLY TIPPED TO ANTERIORMEDIAL AS THERE IS NO GAP BETWEEN THE PROXIMAL AND THE DISTAL PART ON THE MEDIAL SIDE BUT ON THE LATERAL. THE X-RAY DATED (B)(6) 2018 SHOWS THE SITUATION SHORTLY AFTER THE REVISION OF THE REVITAN STEM AS THE STAPLES OF THE SKIN SUTURE ARE STILL VISIBLE. DEVICES ANALYSIS: VISUAL EXAMINATION; THE CONNECTION PIN OF THE REVITAN STEM IS FRACTURED IN THE NON-BLASTED AREA. THE FRACTURE IS LOCATED APPROX. 1 TO 6 MM DISTAL OF THE PROXIMAL END 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 ARE MAINLY POLISHED SO THAT THERE ARE ONLY SOME REMAINS OF THE FRACTURE STRUCTURE VISIBLE. THE LATTER POINTS TO A FATIGUE FRACTURE STARTING FROM THE LATERAL SIDE. THERE IS A DRILL HOLE ON THE FRACTURE SURFACE OF THE DISTAL FRACTURE PART. IT SEEMS THAT THE PROXIMAL FRACTURE SURFACE HAS TWO LEVELS WHEREAS THE DISTAL EXHIBITS ONLY ONE (FIG. 7). THEREFORE A THIN METALLIC SLICE BETWEEN THE TWO LEVELS OF THE PROXIMAL FRACTURE SURFACE SEEMS TO BE MISSING. THE CURVATURE OF THE BEACH MARKS ALSO INDICATES A FRACTURE ORIGIN ON THE LATERAL SIDE. THE INSIDE OF THE DISTAL PART¿S BODY IS DAMAGED. ON THE FACE SURFACE OF THE STEM BODY A MARK MOST PROBABLY DERIVING FROM THE PROXIMAL TRIAL PART CAN BE RECOGNIZED. THE EDGE OF THE FACE SURFACE IS PARTIALLY DAMAGED. THE TWO SHOULDERS ARE DEFORMED AND WORN. THE PROXIMAL AREA OF THE STEM BODY¿S ANCHORING SURFACE ESPECIALLY THE TAPERED AREA IS HEAVILY DAMAGED. ON THE LATERAL AS WELL AS ON THE LATERAL-POSTERIOR SIDE OF THE ANCHORING SURFACE OF THE DISTAL PART DRILL HOLES CAN BE FOUND. OTHER DAMAGE SUCH AS SCRATCHES AND INSTRUMENT MARKS IS VISIBLE MOSTLY IN THE FINNED PORTION OF THE DISTAL PART. IT IS ASSUMED THAT MOST OF THE DAMAGE DERIVED FROM THE REVISION SURGERY. THERE ARE BONE ATTACHMENTS ON THE ENTIRE ANCHORING SURFACE. ON THE PROXIMAL FRACTURE PART OF THE CONNECTION PIN THERE IS AN ALMOST CIRCUMFERENTIAL STRIPE ADJACENT TO THE FRACTURE SURFACE. CLOSER INSPECTION OF THE STRIPE WITH A LOW POWER MICROSCOPE (LEICA MZ16 A, EQ-ID WNT-03-RSR-540-151663) REVEALED POLISHING, LITTLE SMEARED METAL, CORROSION AND POSSIBLE CRACKS. THE MEDIAL SHOULDER OF THE FACE SURFACE OF THE PROXIMAL PART IS PARTIALLY POLISHED. THE ANTERIOR EDGE OF THE LATERAL SHOULDER IS SLIGHTLY POLISHED AS WELL. THE PROXIMAL PART EXHIBITS FEW SCRATCHES ON THE LATERAL AND ANTERIOR SIDE AND AROUND THE STEM NECK. ON THE LATTER FEW SPOT-LIKE DISCOLORATIONS ARE NOTICEABLE THAT PROBABLY CAN BE ATTRIBUTED TO THE USE OF AN ELECTROSURGICAL INSTRUMENT (CAUTER). THE ANCHORING SURFACE OF THE PROXIMAL FRACTURE PART IS POLISHED TO A SHINE MEDIAL-POSTERIOR. ADDITIONALLY, THE POLISHED AREA IS NERVED BY MORE PRONOUNCED SHORT TRANSVERSE POLISHED LINES THAT CONTINUE TO THE POSTERIOR SIDE. POSTERIORLATERAL IN THE PROXIMAL AREA SLIGHTLY POLISHED TRANSVERSE LINES AND SPOTS ARE VISIBLE. REMAINS OF BONE ONGROWTH COULD NOT BE DETECTED ON THE PROXIMAL FRACTURE PART. THE ARTICULATION SURFACE OF THE COCR HEAD PRESENTS NUMEROUS FINE SCRATCHES AS WELL AS MATT APPEARING AREAS WHICH ARE AGGLOMERATIONS OF MANY FINE SCRATCHES. THERE ARE ALSO SOME SPOTS ON THE BEVEL AND BELOW THE EQUATOR THAT PROBABLY CAN BE ATTRIBUTED TO THE USE OF AN ELECTROSURGICAL INSTRUMENT (CAUTER). THE HIP PROSTHESIS WAS REVISED AFTER APPROXIMATELY 9 YEARS IN VIVO DUE TO A FRACTURE OF THE CONNECTION PIN OF THE REVITAN STEM. THERE IS ONLY LITTLE CLINICAL INFORMATION AT HAND. IT SEEMS THAT THE PATIENT RECEIVED A PRIMARY CEMENTED HIP PROSTHESIS DUE TO A FEMORAL NECK FRACTURE IN (B)(6) 2007. IN 2009 THE STEM OF THE HIP PROSTHESIS WAS REVISED DUE TO LOOSENING AND A REVITAN STEM WAS IMPLANTED. THE X-RAY AT HAND DATED (B)(6) 2008 COULD ALREADY RAISE THE SUSPICION OF A LOOSENING OF THE STEM (POSSIBLE SLIGHT SUBSIDENCE AND RADIOLUCENT LINE BETWEEN CEMENT AND BONE). THE EXACT IMPLANTATION DATE OF THE REVITAN STEM IS UNKNOWN. THE FIRST AVAILABLE X-RAY, (B)(6) 2012, IS ABOUT 3 YEARS AFTER REVISION. THERE ARE SCLEROTIC LINES VISIBLE ON THE MEDIAL SIDE UNTIL A LITTLE BELOW THE DISTAL END OF THE TAPERED AREA OF THE STEM BODY AND ON THE LATERAL SIDE AT LEAST UNTIL THE HEIGHT OF THE STEM¿S JUNCTION BETWEEN ITS PROXIMAL AND THE DISTAL PART. THERE IS A GAP BETWEEN THE SCLEROTIC LINE MARKING THE BONE¿S BORDER AND THE IMPLANT. COMPARING THIS X-RAY TO THE PREVIOUS ONE FROM 2008 THE SCLEROTIC LINES CAN BE RELATED TO THE BONE BED OF THE PRIMARY STEM. HOWEVER, DUE TO THE MISSING SECOND VIEW X-RAYS ONLY THE STEM¿S ANCHORING SITUATION IN ML DIRECTION CAN BE ASSESSED. BECAUSE OF THE CHANGED APPEARANCE OF THE JUNCTION BETWEEN THE PROXIMAL AND THE DISTAL PART SEEN ON THE X-RAY DATED (B)(6) 2017, IT COULD PROBABLY BE ASSUMED THAT THE FRACTURE OF THE CONNECTION PIN HAD AT LEAST BEEN STARTED. AN X-RAY SHOWING THE SITUATION SHORTLY BEFORE REVISION, WHICH MOST POSSIBLY WAS PERFORMED SOMETIME BETWEEN END OF (B)(6) 2018, IS NOT AT HAND. THE REVITAN STEM IS FRACTURED AT THE CONNECTION PIN DUE TO FATIGUE IN THE NON-BLASTED AREA SOME MILLIMETERS DISTAL OF THE PROXIMAL END OF THE DISTAL STEM PART. BOTH FRACTURE SURFACES ARE MAINLY POLISHED WHICH INDICATES THAT THE FRACTURE PROBABLY OCCURRED FOR SOME TIME BEFORE THE REVISION. THE FRACTURE ORIGIN IS LOCATED ON THE LATERAL SIDE OF THE STEM. IT SEEMS THAT THE PROXIMAL FRACTURE SURFACE SHOWS TWO LEVELS WHILE THE DISTAL FRACTURE SURFACE HAS ONLY ONE LEVEL. THEREFORE A THIN METAL SLICE BETWEEN THE LEVELS COULD BE MISSING. ON THE PROXIMAL FRACTURE PART A CIRCUMFERENTIAL STRIPE ADJACENT TO THE FRACTURE SURFACE REVEALED POLISHING, LITTLE SMEARED METAL, CORROSION AND POSSIBLE CRACKS. IT IS UNKNOWN IF THAT STRIPE EXISTED ALREADY BEFORE THE START OF THE FRACTURE AND IS ASSOCIATED WITH IT OR DEVELOPED EXCLUSIVELY AS A CONCOMITANT. BONE ATTACHMENTS ARE VISIBLE ON THE ENTIRE ANCHORING SURFACE OF THE DISTAL PART. HOWEVER, ON THE PROXIMAL PART NO REMAINS OF BONE COULD BE DETECTED. FURTHER, ON THE PROXIMAL PART A POLISHED AREA AS WELL AS TRANSVERSE POLISHED LINES AND SPOTS COULD INDICATE LOOSENING / MOVEMENTS AGAINST THE BONE. IT IS UNKNOWN IF THESE EXISTED ALREADY BEFORE THE START OF THE FRACTURE AND ARE ASSOCIATED WITH IT OR DEVELOPED EXCLUSIVELY AS A CONCOMITANT. BASED ON THE ABOVE DESCRIBED FINDINGS IT CAN BE ASSUMED THAT THE STEM DID NOT HAVE SUFFICIENT PROXIMAL BONE SUPPORT STARTING FROM THE TIME OF IMPLANTATION. THIS IN COMBINATION WITH THE PATIENT FACTORS, E.G. HIGH ACTIVITY LEVEL, AS WELL AS THE SURFACE CHANGES OBSERVED ON THE CONNECTION PIN MAY HAVE CONTRIBUTED TO THE SEQUENCE OF EVENTS FINALLY RESULTING IN THE FATIGUE FRACTURE OF THE STEM. IT IS UNKNOWN TO WHICH EXTENT EACH FACTOR HAD AN INFLUENCE ON THE SEQUENCE OF EVENTS AND IF THERE WERE OTHER INFLUENCING FACTORS. CORRECTIVE AND/OR PREVENTIVE ACTIONS HAVE BEEN INITIATED TO PREVENT REOCCURRENCE OF POTENTIAL ¿PIN BREAKAGES¿ OF THE REVITAN REVISION HIP SYSTEM IN THE FUTURE. ZIMMER GMBH DECIDED TO INITIATE A FIELD ACTION IN ORDER TO PROACTIVELY INFORM THE SURGEONS ABOUT HIGH RISK PATIENTS AS THEY MIGHT NOT BE AWARE OF THE EXPLICIT WARNING IN THE IFU. THE ACTION WAS INITIATED ON JANUARY 13TH 2017. AS THE ACTUAL DEVICE REPORTED IN SECTION D IS NOT MARKETED IN USA, THE USA/FDA IS NOT AFFECTED FROM THIS NOTIFICATION. ZIMMER BIOMET 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. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. 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 THE DEVICE YET, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION.: 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 K071723. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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 HAD A REVISION PROCEDURE APPROX. NINE YEARS POST-IMPLANTATION DUE TO IMPLANT FRACTURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149231 | REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 24/200 | LZO | ZIMMER GMBH | N/A | 2465478 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization| R | HEAD, ITEM# 14280720, LOT# 2314257| REVITAN PROXIMAL, ITEM# 0100402075, LOT# 2453478 |