Model Number 1365-52-000 |
Device Problem
Naturally Worn (2988)
|
Patient Problems
Adhesion(s) (1695); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Distress (2329); Metal Related Pathology (4530); Swelling/ Edema (4577)
|
Event Date 12/17/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.Occupation: lawyer.(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.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
|
Pinnacle litigation complaint received ad 13 dec 2022.Patient was revised was due to heavy metal poisoning from the toxic heavy metals.Records also alleges pain, injury, suffered additional scar tissue formation, metallosis, metal wear, loss of enjoyment of life, limitation of daily activities, emotional trauma and distress.Doi: (b)(6), 2008, dor: (b)(6), 2021, unk hip.
|
|
Event Description
|
After review of the medical records the patient was revised to address metal on metal with intrapelvic mass.Operative note reported anterior fluid filled pseudotumor was decompressed and the lining of the structure was removed and sent for pathology.Clinical visit on (b)(6) 2019 reported trochanteric bursitis.Doi: (b)(6) 2008, dor: (b)(6) 2021, affected side: left hip.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.H6 clinical code: metal related pathology (e1618) is used to capture blood heavy metal increased and metal poisoning.
|
|
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 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
|
|
Event Description
|
Additional information received indicated that the patient was dislocated on (b)(6) 2022 while sitting on the floor.The patient was having mild pain, intensity was 3/10.Patient denied having any fever, chills or calf pain.Patient was not requiring narcotic use at this time.The patient was treated via closed reduction.
|
|
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
|
|
Search Alerts/Recalls
|
|