Catalog Number UNK HIP FEMORAL HEAD METAL ASR |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)
|
Patient Problems
Ossification (1428); Fall (1848); Foreign Body Reaction (1868); Inadequate Osseointegration (2646); Limb Fracture (4518); Metal Related Pathology (4530); Insufficient Information (4580)
|
Event Date 08/16/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
Product complaint # (b)(4).D4-the device catalog number is unknown; therefore, udi is unavailable.No 510(k) number provided because this implant is sold internationally with different indications for use; it was sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Article entitled " long ¿ term survivorship and clinical results of the navigated withdrawn asr written by johannes h.M.Van ochtena, dariusch arbabb, peer eyselc, and dietmar p.König was published in journal of orthopaedics on august 16, 2018 was reviewed.Primary goals of the study were to present the mid ¿ to long - term survivorship and clinical, radiological and metal serological results of the first stem ¿ navigated asr resurfacing at our clinic.Secondary goals were to determine the influence of stem ¿ navigation on the outcome and risk factors for revision in our cohort.33 hips were implanted with asr hemi implants.Adverse events: at final follow ¿ up eight revisions had been performed.In five patients the asr prosthesis was revised because of armd.In one patient the stem component showed signs of aseptic loosening and was revised and in one patient the stem component was revised after a fracture due to a direct fall on the hip, in one patient the prosthesis was revised because of unexplained complaints.Median co value was 1.15 (0.3¿28.3) ppb.Median cr value was 0.95 (0.1¿11.3) ppb.Heterotopic ossifications were observed in nine prostheses.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.
|
|
Search Alerts/Recalls
|
|