ALPHA INSERT, PE, JJ/28
Report
- Report Number
- 0009613350-2019-00305
- Event Type
- Injury
- Date Received
- May 14, 2019
- Date of Event
- April 8, 2019
- Report Date
- November 29, 2019
- Manufacturer
- ZIMMER GMBH
- Product Code
- KWB
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
Narratives
INVESTIGATION RESULTS WERE MADE AVAILABLE. DHR-REVIEW: REF#: 01.00010.210 LOT#: 2107531: YIELD: 48. DELIVERED: 48. 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: MEDICAL : REVISION DUE TO WEAR. EVENT DESCRIPTION: IT WAS REPORTED THAT THE ALPHA INSERT AND THE SULOX HEAD WERE REVISED DUE TO WEAR OF THE ALPHA INSERT AND DUE TO PAIN. REVIEW OF RECEIVED DATA: IMPLANTATION REPORT, (B)(6) 2004. INDICATION FOR SURGERY: CLINICALLY AND RADIOLOGICALLY COXARTHROSIS WITH CORRESPONDING SUBJECTIVE SUFFERING. SURGERY: IN SUPINE POSITION A LONGITUDINAL INCISION VIA GREATER TROCHANTER WITH A TRANSGLUTEAL ACCESS TO THE ANTERIOR JOINT CAPSULE IS PERFORMED. AN OSTEOTOMY OF THE FEMORAL NECK IS DONE AND THE FEMORAL HEAD WITH MISSING CARTILAGE IN THE MAIN DORSAL LOADING AREA IS REMOVED. THE ACETABULUM IS SHOWN AND PREPARED STEP BY STEP TO A SIZE 54. A FITMORE SHELL SIZE 54 CAN BE INTRODUCED STABLE IN THE USUAL ORIENTATION AND THE POLYETHYLENE INLAY IS INSERTED. THE STEM AND HEAD ARE IMPLANTED WITHOUT ANY PROBLEMS. AFTER REDUCTION, THE JOINT SHOWS A STABLE CONDITION WITHOUT DISLOCATION TENDENCY. REVISION REPORT, (B)(6) 2019: INDICATION FOR SURGERY: THE PATIENT COMPLAINS OF HIP PAIN. AFTER APPROPRIATE CLARIFICATIONS, THIS CAN BE ATTRIBUTED TO WEAR OF THE POLYETHYLENE INSERT. THEREFORE, THE INSERT AND THE HEAD ARE REPLACED VIA AN ANTERIOR APPROACH. SURGERY: THE JOINT CAPSULE IS THICKENED TO 10 - 15 MM, AND THERE IS AGAIN A THICK, CHRONIC SYNOVITIS. THERE IS ALMOST NO EFFUSION IN THE JOINT. HOWEVER, DEPOSITS CANNOT BE IDENTIFIED IN THE TISSUE. THE NEOCAPSULE IS PARTLY OSSIFIED. PROGRESSIVE CAPSULECTOMY IS PERFORMED FROM ANTERIOR TO LATERAL AS WELL AS INFEROMEDIAL. ONCE ENOUGH CAPSULECTOMY HAS BEEN DONE TO DISLOCATE THE PROSTHESIS, THE HEAD IS KNOCKED OFF IN SITU. THE TAPER HAS ONLY MINIMAL CORROSION. THE PROSTHESIS IS DISLOCATED IN EXTERNAL ROTATION. SAMPLES FOR HISTOPATHOLOGICAL AND MICROBIOLOGICAL EXAMINATION WERE TAKEN FROM THE NEOCAPSULE AT VARIOUS LOCATIONS. THE CAPSULECTOMY IS COMPLETED UNTIL THE INSERT CAN BE LEVERED OUT OF THE SHELL USING A CHISEL. THE POLE PIN IS BROKEN OFF, OR ABRADED. HOWEVER, THERE ARE NO PATHOLOGICAL DEPOSITS IN THE INTERFACE BETWEEN SHELL AND INSERT. THE WEAR OF THE INSERT IS MACROSCOPICALLY VISIBLE, WITH A PRONOUNCED THINNING OF THE POLYETHYLENE IN THE MAIN LOADED ZONE. THE INFERIOR HEMISPHERE OF THE BEARING HAS A YELLOWING DUE TO THE EXPECTED FATTY DEPOSITS. THE HEAD IS CLEARLY DECENTERED IN THE INSERT. THE OSSIFICATIONS AT THE EDGE OF THE SHELL ARE REMOVED. THE REMAINING PROCEDURE DESCRIBES THE IMPLANTATION OF THE NEW COMPONENTS AND IS NOT RELEVANT TO THE CASE. PATHOLOGY REPORT: AS MENTIONED IN THE REVISION REPORT SAMPLES WERE TAKEN AND PATHOLOGICAL ANALYSIS WAS PERFORMED. IT IS DESCRIBED THAT MACROSCOPICALLY THE EXCERPTS ARE PARTLY BEIGE, FOCAL WITH PLAQUE-LIKE YELLOW DEPOSIT. THE DIAGNOSIS STATES THAT THERE IS FIBROLIPOMATOUS TISSUE EXCERPTS WITH SCARRING FIBROSIS AND PRONOUNCED HISTIOCYTIC PARTIALLY GIANT-CELL INFLAMMATORY REACTION. IT IS ALSO COMMENTED THAT THERE IS NO CONVENTIONAL-HISTOLOGICAL EVIDENCE OF FOREIGN MATERIAL. ACCORDING TO MORAWIETZ ET AL, UP TO FIVE NEUTROPHIL GRANULOCYTES ARE FOUND PER TEN HPF. X-RAYS: BASED ON THE FILE NAME THE X-RAYS CAN BE CHRONOLOGICALLY ORDERED AS FOLLOWS. EACH SET OF X-RAYS INCLUDED A PELVIS AP VIEW AND A SECOND VIEW. ONLY X-RAYS RELEVANT TO THE CASE WERE INCLUDED AS PICTURES IN THE REPORT. OBSERVATIONS AND COMPARISONS TO THE PREVIOUS X-RAYS ARE SUMMARIZED BELOW. (B)(6) 2004: TAKEN BEFORE THE IMPLANTATION SURGERY AND THEREFORE NOT PART OF THE INVESTIGATION. (B)(6) 2004: SITUATION AFTER THE IMPLANTATION. INCLINATION: 49.° APRIL 19, 2004: THE CONTRAST OF THE IMAGE IS NOT COMPARABLE WITH THE PREVIOUS X-RAYS. THERE ARE NO OBVIOUS CHANGES TO THE PREVIOUS X-RAYS. (B)(6) 2005 NO OBVIOUS CHANGES TO THE PREVIOUS X-RAYS. (B)(6) 2009: NO CHANGES OF THE CUP'S AND THE STEM'S POSITION CAN BE SEEN WHEN COMPARED TO THE PREVIOUS SET OF X-RAYS. THE INTERFACES BETWEEN THE BONE AND THE IMPLANT DO NOT SHOW ANY OBVIOUS CHANGES. NOV 22, 2018: INCLINATION: 49°. IRREGULAR BONE STRUCTURE IN THE GREATER TROCHANTER. FEMORAL HEAD IS NO LONGER CENTERED WITHIN THE CUP. RADIOLUCENT LINE PROXIMAL FROM THE CUP¿S RIM TO THE FIN. RADIOLUCENT LINE AT THE MEDIAL INTERFACE BETWEEN STEM AND CALCAR. RADIOLUCENT LINE POSTEROLATERAL OF THE STEM IN THE PROXIMAL AREA. (B)(6) 2018: SEVERAL MRI SECTIONS WERE RECEIVED BUT WERE NOT FURTHER ANALYZED. (B)(6) 2019: TAKEN AFTER THE REVISION SURGERY AND THEREFORE NOT PART OF THE INVESTIGATION. DEVICES ANALYSIS: VISUAL EXAMINATION: THE ARTICULATION SIDE EXHIBITS SCRATCHES, CUTS AND INDENTS MOST LIKELY FROM THE REVISION SURGERY. ON THE INSERT'S RIM AS WELL AS ALONG THE EDGE OF THE SPHERICAL CALOTTE SIGNS OF LAYER DELAMINATION CAN BE OBSERVED. IN ONE AREA THE EDGE OF THE SPHERICAL CALOTTE SHOWS TRAPPED BODY FLUIDS UNDERNEATH THE UPPER POLYETHYLENE LAYER AND IS DEFORMED OUTWARDS. THE EDGE OF THE SPHERICAL CALOTTE DOES NOT FORM A CIRCLE ANYMORE AND HAS AN OVAL APPEARANCE. UNDER CERTAIN LIGHTING CONDITIONS A CLEAR BORDERLINE BETWEEN THE LOADED AND THE UNLOADED AREA CAN BE NOTICED. IN THE LOADED AREA CLOSE TO THE BORDERLINE AN ORANGE PEEL- AND PINPRICK-LIKE STRUCTURE IS RECOGNIZABLE BY CLOSER INSPECTION WITH A BINOCULAR. THE MAIN LOADED AREA IS LOCATED TOWARDS THE RIM AND APPEARS MATT AND MORE WHITISH IN COLOR. ADJACENT TO THE MAIN LOADED AREA A SHINY POLISHED AND SLIGHTLY YELLOWISH DISCOLORED AREA CAN BE OBSERVED. MACHINING MARKS ARE STILL VISIBLE IN THE UNLOADED AREA. ON THE ANCHORING SIDE OF THE INSERT, THE LATERAL SURFACE OF THE RIM ALSO EXHIBITS SIGNS OF DELAMINATION AND SOME DAMAGE FROM THE REVISION SURGERY. IN THE LOADED AREA OF THE ANCHORING SIDE THE MACHINING MARKS ARE OBLITERATED. IMPRINTS OF THE SHELL¿S CONTOUR AND ITS LASER MARKING CAN BE SEEN (ARTICLE NUMBER AND SIZE). THE MACHINING MARKS ARE STILL VISIBLE IN THE UNLOADED AREA. TWO CLEAR INDENTATIONS OF THE SHELL¿S ANTI-ROTATIONAL SPIKES CAN BE OBSERVED INDICATING PROPER FIXATION WITHIN THE SHELL. THE SMALL REMAINING PART OF THE POLE PIN IS DEFORMED AND SHOWS A FRACTURE SURFACE WITH TINY WHITISH AREAS. A THREAD-LIKE INDENTATION AND A SQUEEZED DOWN PORTION OF THE PIN CAN BE RECOGNIZED ON ONE SIDE OF THE PIN¿S LATERAL AREA. THE SULOX¿ CERAMIC HEAD IS INCONSPICUOUS. WEAR MEASUREMENTS: THE WEAR MEASUREMENT OF THE ARTICULATION SURFACE OF THE PE ALPHA INSERT WAS CARRIED OUT ON A 3D MEASURING MACHINE TYPE CMM5, SIP GENEVA. TO PERFORM THE WEAR MEASUREMENTS A SMALL POLYETHYLENE LIP HAD TO BE REMOVED. FOR THE INSERT THE CMM MEASUREMENT DETECTED A WEAR ZONE CLOSE TO THE BEVEL AS ALREADY SEEN DURING THE VISUAL EXAMINATION. THE TOTAL, LINEAR WEAR VALUE IS 1.48 MM WHICH RESULTS IN AN ANNUAL WEAR RATE OF APPROXIMATELY 0.1 MM. DUE TO THE POSITION OF THE LOADED ZONE IT HAS TO BE ASSUMED THAT THE WEAR AREA FOR THE INSERT COULD NOT BE MEASURED ENTIRELY, BECAUSE OF THE METHOD¿S LIMITATION. THEREFORE, THE ABOVE GIVEN WEAR VALUE FOR THE INSERT DOES NOT REFLECT THE TRUE AMOUNT OF WEAR. SEMLITSCH ET AL. REPORTED THAT THE EXPECTED POLYETHYLENE WEAR RATE FOR CERAMIC HEADS (ALUMINUM OXIDE FOR DIAMETERS 28 AND 32 MM) COMBINED WITH POLYETHYLENE CUPS MADE OF CONVENTIONAL POLYETHYLENE IS BETWEEN 0.05 AND 0.15 MM/YEAR. REVIEW OF PRODUCT DOCUMENTATION: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. THE COMPATIBILITY CHECK FOR THE SULOX HEAD 28 AND THE ALPHA INSERT JJ/28 WAS PERFORMED AND SHOWED THAT THIS PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. DUE TO MISSING DEVICE IDENTIFICATION OF THE FITMORE CUP AND THE CLS STEM THE COMPATIBILITY OF THE WHOLE THA SYSTEM COULD NOT BE REVIEWED. CONCLUSION SUMMARY: AFTER 15 YEARS AND 1 MONTH IN VIVO THE PE ALPHA INSERT AND SULOX¿ CERAMIC HEAD WERE REVISED DUE TO PAIN WHICH COULD BE ATTRIBUTED TO WEAR OF THE POLYETHYLENE INSERT. THE WEAR ON THE INSERT CAN CLEARLY BE SEEN BY NAKED EYE. THE EDGE OF THE SPHERICAL CALOTTE DOES NOT FORM A CIRCLE ANYMORE AND HAS AN OVAL APPEARANCE. THE APPEARANCE OF THE SPHERICAL CALOTTE MATCHES WITH THE OBSERVATION MADE ON THE PELVIS OVERVIEW X-RAYS. THE VISUAL EXAMINATION REVEALED A WORN AREA TOWARDS THE RIM INCLUDING THE EDGE OF THE SPHERICAL CALOTTE. THE INCLINATION ANGLE MEASURED AMOUNTED TO APPROXIMATELY 49°. THIS COULD POSSIBLY HAVE CONTRIBUTED TO A SITUATION WHERE THE HEAD ARTICULATED MORE TOWARDS THE RIM THAN THE CENTER. ACCORDING TO THE SURGICAL TECHNIQUE AN INCLINATION ANGLE BETWEEN 40° AND 45° SHOULD BE CONSIDERED. A DIFFERENT INCLINATION ANGLE COULD POSSIBLY CONTRIBUTE TO INCREASE WEAR. HOWEVER, THE MEASURED ANNUAL WEAR RATE IS WITHIN THE EXPECTED RANGE COMPARED TO. DUE TO THE LIMITATIONS OF THE WEAR MEASUREMENT METHOD THE ARTICULATION SURFACE COULD NOT BE MEASURED ENTIRELY. CONSIDERING THE APPEARANCE OF THE INSERT IT SEEMS TO BE UNLIKELY THAT A COMPLETE MEASUREMENT WOULD RESULT IN AN ANNUAL WEAR RATE ABOVE THE EXPECTED RANGE. THE APPEARANCE OF THE INSERT (LAYER DELAMINATION AND FRACTURED OFF POLE PIN) POINTS TO EMBRITTLEMENT OF THE MATERIAL DUE TO OXIDATION. IT IS A KNOWN PHENOMENON THAT IN VIVO OXIDATION OCCURS ONCE A CONVENTIONAL POLYETHYLENE COMPONENT IS IMPLANTED. IN VIVO OXIDATION MIGHT BE VERY INDIVIDUAL AND PATIENT SPECIFIC. THE SLIGHT YELLOWING ON THE INSERT CAN BE ATTRIBUTED TO THE ABSORPTION AND POSSIBLY DIFFUSION OF ORGANIC SUBSTANCES FROM THE SYNOVIAL FLUID. OBLITERATED MACHINING MARKS ON THE ANCHORING SIDE OF THE INSERT AND THE IMPRINTS OF THE SHELL'S CONTOUR ARE SIGNS OF BACKSIDE CHANGES. IT REMAINS UNKNOWN IF AND TO WHAT EXTEND THE ABOVE MENTIONED OBSERVATIONS CONTRIBUTED TO THE PATIENT'S SYMPTOMS. THE PATHOLOGY REPORT STATES THAT THERE IS NO CONVENTIONAL-HISTOLOGICAL EVIDENCE OF FOREIGN MATERIAL. THE MEASURED ANNUAL WEAR RATE IS WITHIN THE EXPECTED RANGE. BASED ON THE RETRIEVAL INVESTIGATION IT CANNOT BE DETERMINED IF AND TO WHAT EXTEND OTHER PATIENT, IMPLANT AND / OR SURGICAL RELATED FACTORS MIGHT HAVE INFLUENCED THE SITUATION LEADING TO THE REVISION SURGERY. 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 FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2019-00306-1.
INVESTIGATION RESULTS ARE NOW AVAILABLE.
CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATE DETAIL OF PRODUCT: ITEM NUMBER 172807, ITEM NAME SULOX, HEAD, L,¸ 28/+3.5, TAPER 12/14, LOT / # UNKNOWN. ITEM NUMBER UNKNOWN, ITEM NAME FITMORE CUP HIP IMPL WIN GEN, LOT # UNKNOWN. ITEM NUMBER UNKNOWN, ITEM NAME CLS STEM HIP IMPL WIN GEN, LOT # UNKNOWN. ITEM NUMBER UNKNOWN, ITEM NAME SULOX HEAD HIP IMPL WIN GEN, LOT # UNKNOWN. THE MANUFACTURER RECEIVED X-RAYS AND OTHER SOURCE DOCUMENTS FOR REVIEW. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS PENDING. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. 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 PATIENT UNDERWENT REVISION SURGERY DUE TO IMPLANT WEAR AND PROGRESSIVE INCREASED PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 400765 | ALPHA INSERT, PE, JJ/28 | N/A | KWB | ZIMMER GMBH | N/A | 2107531 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | REFER TO H10 |