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	87	89
Insufficient Device Problem Information	22	22
Device Dislodged or Dislocated	11	11
Naturally Worn	9	9
Fracture	7	8
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
Inappropriate or Unexpected Reset	1	1
Osseointegration Problem	1	1
Loss of Osseointegration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	56	56
Joint Dislocation	21	21
Insufficient Information	14	14
No Clinical Signs, Symptoms or Conditions	12	13
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
Medical device site infection	2	2
Post Operative Wound Infection	2	2
Osteolysis	2	2
Ambulation or Postural Difficulties	2	2
Bacterial Infection	2	2
Wound Dehiscence	1	1
Inadequate Osseointegration	1	1
Joint effusion	1	1
Unspecified Musculoskeletal problem	1	1
Skin Inflammation/ Irritation	1	1
Cyst(s)	1	1
Synovitis	1	1
Implant Pain	1	1
No Known Impact Or Consequence To Patient	1	1
High White Blood Cell Count	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
Joint Impingement	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1