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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented
Definition 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.
Product CodeOQI
Regulation Number 888.3353
Device Class 2


Premarket Reviews
ManufacturerDecision
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAXX ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 4 4
2019 6 6
2020 5 5
2021 5 5
2022 4 4
2023 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 24 24
Device Dislodged or Dislocated 4 4
Fracture 4 4
Separation Failure 3 3
Insufficient Information 2 2
Appropriate Term/Code Not Available 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Difficult or Delayed Separation 1 1
Difficult or Delayed Positioning 1 1
Positioning Failure 1 1
Material Erosion 1 1
Biocompatibility 1 1
Detachment of Device or Device Component 1 1
Device-Device Incompatibility 1 1
Difficult to Insert 1 1
Device Appears to Trigger Rejection 1 1
Unstable 1 1
Device Damaged Prior to Use 1 1
Loss of Osseointegration 1 1
Expiration Date Error 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 15 15
Pain 7 7
No Clinical Signs, Symptoms or Conditions 5 5
Joint Dislocation 4 4
No Known Impact Or Consequence To Patient 4 4
Metal Related Pathology 3 3
Failure of Implant 3 3
Insufficient Information 2 2
Fungal Infection 2 2
No Consequences Or Impact To Patient 2 2
Bacterial Infection 2 2
Fall 2 2
Bone Fracture(s) 1 1
Debris, Bone Shedding 1 1
Hip Fracture 1 1
Inflammation 1 1
Irritability 1 1
Post Operative Wound Infection 1 1
Osteolysis 1 1
Unequal Limb Length 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Zimmer, Inc. II Oct-05-2022
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