Catalog Number 999800752 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Foreign Body Reaction (1868); Pain (1994); Anxiety (2328); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Depression (2361); Osteolysis (2377); Metal Related Pathology (4530); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 12/10/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
Product complaint # (b)(4).Initial reporter occupation: lawyer if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Asr medical records received.After review of the medical records the patient was revised to address mechanical complication of internal ortho device, metallosis and elevated metal ions.Operative note reported moderate amount of cloudy fluid within the joint.There were some osteolytic areas beneath acetabular component.Doi: (b)(6) 2008.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: the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.An mre (device history record) review will not be performed even when lot code(s) are known.
|
|
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: the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.An mre (device history record) review will not be performed even when lot code(s) are known.
|
|
Event Description
|
Litigation alleges pain, discomfort, elevated metal ions, emotional distress, permanent injuries, disability, disfigurement and economic damages.Doi: (b)(6) 2008.Dor: (b)(6) 2020.Left hip.
|
|
Event Description
|
Pfs alleges heavy metal toxicity, fear, anxiety and depression.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: a4, b5, b7 and h6 (clinical codes).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
|
|
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.Update:10-jan-2023.Update 09-jan-2023 received did not have any additional details to be added in investigation.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 : the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.An mre (device history record) review will not be performed even when lot code(s) are known.
|
|
Search Alerts/Recalls
|