Catalog Number UNK HIP FEMORAL STEM |
Device Problems
Fracture (1260); Osseointegration Problem (3003)
|
Patient Problems
Inadequate Osseointegration (2646); Not Applicable (3189)
|
Event Date 05/02/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Der states that the patient had revision surgery due to a broken s-rom stem.Stem and liner removed.New stem, liner and head implanted.It was also reported that there was loosening of femoral component and sleeve at bone to implant interface.Doi: unknown; dor: (b)(6) 2018; right 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 device history record (dhr) review, was not possible because the required lot code(s) was not provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|