TPLC - Total Product Life Cycle

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Device	hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented
Regulation Description	Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
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 Code	OQI
Regulation Number	888.3353
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	80	82
Insufficient Information	21	21
Device Dislodged or Dislocated	11	11
Naturally Worn	10	10
Fracture	6	7
Therapeutic or Diagnostic Output Failure	3	3
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Unstable	1	1
Device Damaged Prior to Use	1	1
Separation Failure	1	1
Expiration Date Error	1	1
Difficult to Insert	1	1
Positioning Failure	1	1
Difficult or Delayed Separation	1	1
No Apparent Adverse Event	1	1
Inappropriate or Unexpected Reset	1	1
Osseointegration Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	53	53
Joint Dislocation	17	17
Insufficient Information	14	14
No Clinical Signs, Symptoms or Conditions	11	12
Pain	9	11
Joint Laxity	8	8
Failure of Implant	7	8
Metal Related Pathology	3	5
Fungal Infection	2	2
Bone Fracture(s)	2	2
Osteolysis	2	2
Bacterial Infection	2	2
Ambulation Difficulties	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Wound Dehiscence	1	1
Inadequate Osseointegration	1	1
Unspecified Musculoskeletal problem	1	1
Skin Inflammation/ Irritation	1	1
Cyst(s)	1	1
Synovitis	1	1
Implant Pain	1	1
Post Operative Wound Infection	1	1
No Known Impact Or Consequence To Patient	1	1
Loss of Range of Motion	1	1
Unequal Limb Length	1	1
Scar Tissue	1	1
Fluid Discharge	1	1
Subluxation	1	1
Swelling/ Edema	1	1
Irritability	1	1