BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTAN, STEM, RIGHT, UNCEMENTED, 16, TAPER 12/14

    MDR report key: 7565076 · Received June 4, 2018

    Report

    Report Number
    0009613350-2018-00574
    Event Type
    Injury
    Date Received
    June 4, 2018
    Date of Event
    April 30, 2018
    Report Date
    October 23, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY INVESTIGATION RESULT. ADDITIONAL AND CORRECTED INFORMATION ARE FILLED IN THE FOLLOWING FIELDS: DHR REVIEW: 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: REVISION DUE DO INFECTION. EVENT DESCRIPTION: AFTER 15 YEARS AND 10 MONTH THE METASUL ALPHA INSERT WAS REVISED DUE TO INFECTION. REVIEW OF RECEIVED DATA: REVIEW OF AVAILABLE INFORMATION: THE INFORMATION STATED ON THE FRONT PAGE OF THIS REPORT WAS TAKEN FROM AN EMAIL OF THE COMPLAINING SURGEON AS WELL AS FROM THE RECEIVED PRODUCT STICKERS. THE ZIMMER BIOMET PRODUCT EXPERIENCE REPORT (ZPER) DOES NOT CONTAIN ANY ADDITIONAL INFORMATION. EMAIL FROM THE COMPLAINING SURGEON DATED 02 MAY 2018 THE PATIENT HAS THE FOLLOWING ANAMNESIS: PRIMARY IMPLANTATION TOTAL HIP ENDOPROSTHESIS, RIGHT IN 2002 AT (B)(6) POSTOPERATIVE REMOVAL OF A HAEMATOMA 5 DAYS AFTER IMPLANTATION EXCISION OF AN ABSCESS ON THE RIGHT THIGH IN 2008 FISTULA SINCE APPROXIMATELY 2008 EXPLANTATION TOTAL HIP ENDOPROSTHESIS, RIGHT (B)(6) 2018 AT (B)(6) AT LEAST SINCE 2008 THE PATIENT HAS A PERIPROSTHETIC INFECTION WITH FISTULA. LOAD DEPENDING DISCOMFORTS WERE NOT PRESENT AT ANY TIME. SECONDARY DIAGNOSES: DIABETES MELLITUS TYPE II. OBESITY. FARMER. PRODUCT STICKERS. ON THE DOCUMENT WITH THE AFFIXED PRODUCT STICKERS THE DATE 03 JULY 2002 IS NOTED WHAT HAS BEEN INTERPRETED AS DATE OF IMPLANTATION. WITH THE RECEIVED METASUL ALPHA INSERT THE PRODUCTS LISTED IN THE FOLLOWING TABLE WERE IMPLANTED. DEVICE ANALYSIS: VISUAL EXAMINATION: THE METASUL ALPHA INSERT SHOWS DAMAGE, E. G. SCRATCHES, INDENTATIONS, CUT-INS AND SO ON, PROBABLY DERIVING FROM THE REVISION SURGERY MAINLY ON THE POLYETHYLENE RIM OF THE ARTICULATION SIDE. ON THE RIM TWO AREAS EXHIBITING A MIXTURE OF LAYER AND PARTICLE DELAMINATION CAN BE SEEN. THE LARGER OF THESE AREAS MEASURES APPROXIMATELY 20 MM IN LENGTH AND 10 MM IN WIDTH, IS YELLOWISH DISCOLORED AND LOCATED IN AN AREA WHERE A CUT-IN OF THE SAME LENGTH EXISTS ON THE ANCHORING SIDE. FURTHER, THERE ARE TWO SMALL WHITISH AREAS ALONG THE RIM¿S EDGE. ON THE ARTICULATION SURFACE OF THE METASUL INLAY AREAS WITH NUMEROUS FINE SCRATCHES AS WELL AS SMALLER ZONES OF HIGHER SCRATCH DENSITY ARE VISIBLE. THOSE AREAS SURROUND A LESS SCRATCHED APPEARING AREA. IT IS SUPPOSED THAT THE LATTER COULD BE THE LOADED AREA OF THE INSERT WHILE THE AREAS WITH NUMEROUS FINE SCRATCHES FORM AT LEAST A PARTIAL BORDERLINE BETWEEN LOADED AND UNLOADED AREA. THE ANCHORING SIDE OF THE METASUL ALPHA INSERT MIRRORS THE CONTOUR OF ACA SHELL WITH ITS SEVERAL HOLES ARRANGED IN A CIRCLE ADJACENT TO THE FLATTENED POLE AREA. THE HOLES CAN BE RECOGNIZED EITHER BY THE YELLOWING OF THE POLYETHYLENE MOST PROBABLY LOCATED IN THE LOADED AREA OF THE CUP OR BY A SLIGHT INDENTATION. IN THE YELLOWISH DISCOLORED AREA BACKSIDE CHANGES ARE NOTICEABLE. CLOSER INSPECTION OF THE AREA WITH BACKSIDE CHANGES WITH A LOW POWER MICROSCOPE (LEICA MZ16 A, EQ-ID WNT-03-RSR- 540-151663) REVEALED THAT THE ORIGINAL MACHINING LINES ARE OBLITERATED AND TINY METALLIC PARTICLES ADHERING TO THE SURFACE ARE PRESENT. FURTHER A PAIR OF INDENTATIONS ORIGINATING FROM THE SHELL¿S ANTI ROTATIONAL SPIKES CAN BE SEEN. THE POLE PIN OF THE INSERT IS SLIGHTLY DEFORMED ON ONE SIDE. THE EDGE OF THIS AREA APPEARS FRAYED AND THE AREA ITSELF SHOWS A PATTERN OF PARALLEL SCRATCHES. THE DEFORMED AREA IS LOCATED ON THE SAME SIDE AS THE CUT-IN ON THE ANCHORING¿S SIDE RIM. WEAR MEASUREMENT: A WEAR MEASUREMENT WAS NOT PERFORMED AS ONLY ONE PART OF THE METASUL-PAIRING WAS RECEIVED AND FOR ASSESSING THE WEAR RATE THE WEAR VALUES OF BOTH, HEAD AND CUP / INSERT, ARE CONSIDERED. CONCLUSION: AFTER 15 YEARS AND 10 MONTH THE METASUL ALPHA INSERT WAS REVISED DUE TO INFECTION. EVEN THOUGH "DISLOCATION" WAS REPORTED INITIALLY, THIS EVENT COULD NOT BE CONFIRMED AS PART OF THE INVESTIGATION. ON THE RIM OF THE INSERT TWO AREAS EXHIBITING A MIXTURE OF LAYER AND PARTICLE DELAMINATION CAN BE SEEN. AS THE LARGER OF THE TWO AREAS IS LOCATED AT THE SAME POSITION LIKE THE CUT-IN ON THE ANCHORING SIDE IT COULD BE HYPOTHESIZED THAT THIS AREA BECAME MORE OBVIOUS BECAUSE OF THE CUT-IN. THE DELAMINATION AS WELL AS THE TWO SMALL WHITISH AREAS ALONG THE RIM¿S EDGE CAN BE ATTRIBUTED TO OXIDATION OF THE MATERIAL. THE YELLOWING OF THE POLYETHYLENE LINER OF THE METASUL ALPHA INSERT IS DUE TO THE ABSORPTION AND POSSIBLY DIFFUSION OF ORGANIC SUBSTANCES FROM THE SYNOVIAL FLUID. IT IS UNKNOWN IF THE PERIPROSTHETIC INFECTION THE PATIENT SUFFERED FROM COULD HAVE AN INFLUENCE ON THE YELLOWING. ON THE ANCHORING SURFACE OF THE INSERT BACKSIDE CHANGES AND TINY METALLIC PARTICLES ADHERING TO THE SURFACE WERE OBSERVED. THIS COULD POINT TO MICROMOTION BETWEEN THE INSERT AND ITS SHELL. BECAUSE THE DEFORMED AREA OF THE POLE PIN IS LOCATED ON THE SAME SIDE AS THE CUT-IN ON THE ANCHORING¿S SIDE RIM IT IS ASSUMED THAT THE DEFORMED AREA DERIVED FROM REVISION SURGERY WHEN THE INSERT WAS LEVERED OUT FROM THE SHELL. THIS COULD BE SUPPORTED ADDITIONALLY BY THE PATTERN OF PARALLEL SCRATCHES ON THE PIN IN LEVER-OUT DIRECTION. 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 Manufacturer Narrative · 0

    ADDITIONAL: A4, H2. CORRECTION: B4, G4, G7, H3, H10. PATIENT`S WEIGHT WAS RECEIVED AS ADDITIONAL INFORMATION. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY APPROXIMATELY SIXTEEN YEARS POST IMPLANTATION DUE TO DISLOCATION AND INFECTION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    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 WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. INFORMATION OF THE DEVICES WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. 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 FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2018-00572 METASUL ALPHA INSERT, 0009613350-2018-00573 METASUL HEAD, 0009613350-2018-00574 OPTAN STEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY APPROXIMATELY SIXTEEN YEARS POST IMPLANTATION DUE TO DISLOCATION AND INFECTION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407173 OPTAN, STEM, RIGHT, UNCEMENTED, 16, TAPER 12/14 LZO ZIMMER GMBH N/A 2057166

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R ANCHORAGE CAP, ITEM# 4090148, LOT# B147325.| METASUL HEAD, ITEM# 19.28.05, LOT# 2111852.| METASUL INSERT, ITEM# 01.00010.414, LOT# 2101377.| ANCHORAGE CAP, ITEM# 4090148, LOT# B147325| METASUL HEAD, ITEM# 19.28.05, LOT# 2111852| METASUL INSERT, ITEM# 01.00010.414, LOT# 2101377