Hip, Semi-constrained, Cemented, Metal/polymer + Additive, Cemented
Orthopedic · 21 CFR 888.3350
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and uncemented use.
Recent MDR events
8 adverse event reports on file
- LINER 10 HOODED NEU, MP6, HXE-PLUS, 32MMMay 13, 2021Injury1644408-2018-00539
- LINER/NON-HOODED-NEU, MP8, HXE-PLUS, 36MMNov 8, 2020Injury1644408-2016-00891
- X-ALT HIPOct 16, 2019InjuryEncore Medical L.p.1644408-2019-01004
- FMP HIPMar 29, 2016InjuryEncore Medical, L.p.1644408-2016-00219
- RESTORIS TOTAL HIP SYSTEMJul 18, 2013InjuryPipeline Orthopedics Llc3009701876-2013-00012
- RESTORIS ACETABULAR LINERJul 12, 2013InjuryPipeline Orthopedics Llc3009701876-2013-00010
- RESTORIS ACETABULAR LINERApr 26, 2013InjuryPipeline Orthopedics Llc3009701876-2013-00006
- RESTORIS ACETABULAR LINERMar 25, 2013InjuryPipeline Orthopedics Llc3009701876-2013-00004
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
186 firms currently registered for this product code
Zimmer (shanghai) Medical International Trading Co., Ltd.
Shanghai, CN
Zimmer Gmbh
WINTERTHUR Zurich, CH
Isomedix Operations, Inc.
Libertyville, IL, US
Biomet Global Supply Chain Center B.v.
Hazeldonk Noord-Brabant, NL
Zimmer Biomet G.k.
Hiratsuka Kanagawa, JP
Biomet Chile S.a.
Santiago de Chile Region Metropolitana, CL
Zimmer Biomet Korea Ltd.
Seoul, KR
Biomet, Inc.
WARSAW, IN, US
T & L Sharpening, Inc.
Indiana Beach, IN, US
Sterigenics Us, Llc
Lewis Center, OH, US
Zhejiang Biomet Medical Products Co., Ltd.
Jinhua Zhejiang, CN
Zimmer Pte. Ltd.
Singapore South East, SG
Synergy Health Sterilisation Uk Ltd
Daventry Northamptonshire, GB
Sterigenics Us Llc
Gurnee, IL, US
Sterigenics U.s., Llc
Salt Lake City, UT, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.