BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 8841720 · Received July 30, 2019

    Report

    Report Number
    1818910-2019-99675
    Event Type
    Injury
    Date Received
    July 30, 2019
    Report Date
    July 28, 2019
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY: THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. REF. WWCAPA 00780 SUPERSEDED BY MDD CAPA-001226. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    AN ARTICLE ¿RADIOGRAPHICALLY UNDETECTABLE PERIPROSTHETIC OSTEOLYSIS WITH ASR IMPLANTS THE IMPLICATION OF BLOOD METAL IONS¿ BY FILIPPO RANDELLI ET AL REPORTS ON A CONSECUTIVE SERIES OF FOURTEEN ASR REVISIONS (11 FEMALE AND 3 MALES; MEAN AGE - 60.7 YEARS), FOCUSING ON OSTEOLYSIS AND THEIR RADIOGRAPHIC CORRESPONDENCE AND THEIR CORRELATION WITH BLOOD METAL ION LEVELS BETWEEN FEBRUARY 2011 AND JUNE 2012. 3 ASR RESURFACING AND 11 ASR-XLS WERE EXPLANTED. REASONS FOR REVISION WERE EXTREMELY HIGH BLOOD METAL ION LEVELS IN 10 PATIENTS, ASEPTIC CUP LOOSENING IN 4, HIP PAIN IN 9, LARGE INTRAPELVIC PSEUDOTUMOUR IN 1 AND DEEP INFECTION IN 1. IN 8 PATIENTS THERE WAS MORE THAN ONE REASON FOR REVISION, WHEREAS, FOR THE OTHER 6 PATIENTS, 1 WAS REVISED BECAUSE OF UNEXPLAINED HIP PAIN AND 5 BECAUSE OF EXTREMELY ELEVATION OF BLOOD METAL ION LEVELS, EVEN IF PAIN FREE AND WITH A RADIOGRAPHICALLY STABLE IMPLANT. AT REVISION, 7 HIPS REVEALED SEVERE PERIACETABULAR OSTEOLYSIS WHICH WAS RADIOGRAPHICALLY UNDETECTABLE IN 6 AND ASYMPTOMATIC IN 5. 7 HIPS WITH NO ACETABULAR OSTEOLYSIS HAD SIGNIFICANTLY LOWER SERUM CR AND CO ION CONCENTRATIONS COMPARED TO THE 7 HIPS WITH SEVERE ACETABULAR BONE LOSS. ELEVATED BLOOD METAL ION LEVELS SHOULD BE CONSIDERED AS A WARNING OF UNDETECTABLE AND ONGOING PERIPROSTHETIC OSTEOLYSIS IN ASYMPTOMATIC PATIENTS WITH ASR PROSTHESIS. DURING REVISION, CUPS WERE REMOVED WITH EXPLANT BLADES (ZIMMER, WARSAW, IND). A SCREWED SAND BLASTED CONICAL CUP (BICON PLUS, SMITH & NEPHEW) AND A SCREWED HEMISPHERICAL HYDROXYAPATITE COATED CUPS (SPIROFIT PINNACLE, DEPUY ORTHOPAEDICS, WARSAW, INDIANA) WERE USED. CASE #4 PATIENT WITH ASR XL IMPLANTATION RECEIVED REVISION. NOTED ARE THE FOLLOWING PATIENT ADVERSE EVENTS: REVISION SURGERY, ELEVATED METAL IONS, PAIN AND (PER TABLE 1 PAGE 1260). NOTED ARE THE FOLLOWING PRODUCT ADVERSE EVENTS: NO REPORTED PRODUCT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636344 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM KWY DEPUY INTERNATIONAL LTD. 8010379 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention