Catalog Number 999890245 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Adhesion(s) (1695); Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Physical Asymmetry (4573); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 05/05/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Patient had elevated metal ion.Revision notes stated that scar excision was performed including removal of abnormal appearing tissue.A minimal sized fluid collection was evacuated.There was some evidence of corrosion at the trunnion.There was near impingement with extension and external rotation of the hip.The cup was too anteverted and vertical.Leg lengths looked short.Cup, head.And sleeve were removed.Operative findings stated that a local soft tissue response and fluid collection in line with an adverse metal on metal reaction was found.There are some contained boney defects on the acetabular side that twe bone grafted.There was also some posterior superior bone loss and medial.The local soft tissues were stained in a way that is characteristic for a metal on metal failure.Added patient's dob, medical history, and laboratory data.Corrected patient's initials.Added head, sleeve, and stem due to elevated metal ion reported.Added date of implantation.Doi: (b)(6) 2006.Dor: (b)(6) 2020.(left hip).
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.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: previous investigations that have included manufacturing record evaluations (mre) since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.
|
|
Event Description
|
Patient experienced discomfort, managed socks/shoes with some difficulty.Patient has enlarging supra- acetabular cyst which could be related to metal-on-metal failure.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed andthe investigation will be re-opened as necessary.Device history lot : previous investigations that have included manufacturing record evaluations (mre) since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.
|
|
Search Alerts/Recalls
|