Catalog Number UNK HIP ACETABULAR CUP |
Device Problem
Noise, Audible (3273)
|
Patient Problems
Foreign Body Reaction (1868); Pain (1994); Joint Laxity (4526); Physical Asymmetry (4573)
|
Event Date 08/22/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary = no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot = the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
|
|
Event Description
|
Litigation records received.On date (b)(6) 2019 patient had a left hip replacement.The patient complained of personal injury claim of a defective depuy product.Then on date (b)(6) 2022 patient was revised due to unknown reason.Doi: (b)(6) 2019.Dor: (b)(6) 2022.Left hip.
|
|
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.
|
|
Event Description
|
Medical records received.On (b)(6) 2019, the patient received a left total hip arthroplasty to address arthritis, utilizing depuy products--summit femoral stem and ceramic head, paired with pinnacle gription acetabular cup, one 6.5 mm acetabular screw, and a polyethylene liner.Upon discharge on (b)(6) 2019, the patient was deemed to have had a successful, uncomplicated surgery, and radiographs indicated implants were in the appropriate position.On (b)(6) 2022, the patient began experiencing severe hip pain, and then on (b)(6) 2022, heard squeaking coming from her hip, roughly 70% of the time, and began limping due to her pain.On (b)(6) 2022, the patient received imaging of her hip, and was then scheduled for revision surgery of her left hip, due to a diagnosis of ¿failure of orthopedic hardware¿.On (b)(6) 2022, during her left hip revision surgery, the surgeon identified metallosis in her surrounding tissues, a consequence of subluxation of her ceramic femoral head directly articulating against the acetabular cup¿due to the rim of the polyethylene liner having fractured.Her cup and stem were retained, and the head and liner were revised, replacing them with a dual mobility construct.The tissues subject to metallosis were debrided.Her surgery was completed successfully without any complications.On (b)(6) 2023, the patient presented with constant soreness, anterior and lateral pain, occasional numbness in her feet, popping in her hip with rotation, and aggravation of her pain with prolonged sitting/standing/walking.She had had one episode of shooting pain while walking.She also complained that her right hip was not beginning to ¿bother her¿.On (b)(6) 2023, the patient was seen by a joint specialist for her symptoms, which further included occasional groin pain when walking and a sharp pain with ¿happens quickly and then subsides¿.The specialist recommended an ultrasound injection for treatment of possible psoas tendinitis (it is unclear if she received this treatment).The patient is seeking a legal claim due to the failure of her hardware (the fractured polyethylene liner), but at the time of this record, there was no formal litigation.(b)(4) was created to capture the event post revision allegations.
|
|
Search Alerts/Recalls
|
|