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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
MAXX ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 6 6
2020 5 5
2021 5 5
2022 4 4
2023 22 22
2024 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 38 38
Insufficient Information 6 6
Naturally Worn 5 5
Device Dislodged or Dislocated 4 4
Separation Failure 3 3
Fracture 3 3
Unstable 1 1
Device-Device Incompatibility 1 1
Material Erosion 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Detachment of Device or Device Component 1 1
Device Appears to Trigger Rejection 1 1
Biocompatibility 1 1
Loss of Osseointegration 1 1
Difficult to Insert 1 1
Positioning Failure 1 1
Device Damaged Prior to Use 1 1
Expiration Date Error 1 1
Difficult or Delayed Positioning 1 1
Difficult or Delayed Separation 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 25 25
Pain 7 7
Joint Dislocation 6 6
No Clinical Signs, Symptoms or Conditions 6 6
Insufficient Information 6 6
Failure of Implant 4 4
Metal Related Pathology 4 4
No Known Impact Or Consequence To Patient 4 4
Fungal Infection 2 2
Bone Fracture(s) 2 2
Fall 2 2
Joint Laxity 2 2
Bacterial Infection 2 2
No Consequences Or Impact To Patient 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Debris, Bone Shedding 1 1
Cyst(s) 1 1
Inflammation 1 1
Implant Pain 1 1
Osteolysis 1 1
Unequal Limb Length 1 1
Irritability 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Exactech, Inc. II Jan-18-2024
2 Zimmer, Inc. II Oct-05-2022
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