TPLC - Total Product Life Cycle

show TPLC since

Device	prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
Regulation Description	Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
Product Code	MBL
Regulation Number	888.3358
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	255	255
Device Dislodged or Dislocated	30	30
Biocompatibility	21	21
Insufficient Information	21	21
Connection Problem	18	18
Fitting Problem	12	12
Incomplete or Inadequate Connection	10	10
Unintended Movement	10	10
Loosening of Implant Not Related to Bone-Ingrowth	9	9
Loss of Osseointegration	8	8
Migration	8	8
Break	7	7
Failure to Align	7	7
Failure to Osseointegrate	7	7
Positioning Problem	6	6
Loose or Intermittent Connection	5	5
Defective Device	5	5
Patient Device Interaction Problem	5	5
Osseointegration Problem	4	4
Malposition of Device	4	4
Degraded	4	4
Difficult to Insert	4	4
Inadequacy of Device Shape and/or Size	4	4
Compatibility Problem	3	3
Physical Resistance/Sticking	3	3
Naturally Worn	3	3
Positioning Failure	3	3
Nonstandard Device	2	2
Appropriate Term/Code Not Available	2	2
Fracture	2	2
No Apparent Adverse Event	2	2
Patient-Device Incompatibility	2	2
Device-Device Incompatibility	2	2
Unstable	2	2
Misconnection	1	1
Delivered as Unsterile Product	1	1
Device Damaged by Another Device	1	1
Use of Device Problem	1	1
Scratched Material	1	1
Difficult to Remove	1	1
Therapeutic or Diagnostic Output Failure	1	1
Unsealed Device Packaging	1	1
Device Markings/Labelling Problem	1	1
Crack	1	1
Inaccurate Information	1	1
Premature Separation	1	1
Off-Label Use	1	1
Improper or Incorrect Procedure or Method	1	1
Deformation Due to Compressive Stress	1	1
Mechanical Jam	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	91	91
Joint Dislocation	68	68
No Clinical Signs, Symptoms or Conditions	63	63
Failure of Implant	50	50
Injury	41	41
Pain	35	35
Metal Related Pathology	32	32
Insufficient Information	28	28
No Known Impact Or Consequence To Patient	21	21
Osteolysis	20	20
Inadequate Osseointegration	18	18
Bone Fracture(s)	18	18
Joint Laxity	13	13
Hip Fracture	11	11
Arthralgia	11	11
Fall	11	11
Bacterial Infection	10	10
Subluxation	7	7
Swelling/ Edema	7	7
Implant Pain	6	6
Ambulation Difficulties	5	5
Inflammation	5	5
Foreign Body Reaction	5	5
Deformity/ Disfigurement	5	5
Muscle/Tendon Damage	4	4
Loss of Range of Motion	4	4
Post Operative Wound Infection	4	4
Infiltration into Tissue	4	4
No Information	4	4
Impaired Healing	4	4
Ischemic Heart Disease	3	3
Thrombosis/Thrombus	3	3
Nerve Damage	3	3
Discomfort	3	3
Sepsis	3	3
No Consequences Or Impact To Patient	2	2
Purulent Discharge	2	2
Anemia	2	2
Fever	2	2
Synovitis	2	2
Hematoma	2	2
Unequal Limb Length	2	2
Unspecified Tissue Injury	2	2
Solid Tumour	2	2
Scar Tissue	2	2
Failure to Anastomose	2	2
Wound Dehiscence	2	2
Hemorrhage/Bleeding	1	1
Inadequate Pain Relief	1	1
Physical Asymmetry	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Smith & Nephew, Inc.	II	Jun-09-2020