TPLC - Total Product Life Cycle

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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	270	1743
Device Dislodged or Dislocated	31	33
Insufficient Information	23	23
Biocompatibility	22	24
Connection Problem	18	18
Fitting Problem	12	12
Migration	11	11
Loss of Osseointegration	10	10
Incomplete or Inadequate Connection	10	10
Unintended Movement	10	10
Loosening of Implant Not Related to Bone-Ingrowth	10	1480
Osseointegration Problem	9	407
Malposition of Device	7	1074
Failure to Osseointegrate	7	7
Failure to Align	7	7
Patient Device Interaction Problem	7	8
Break	6	6
Material Erosion	6	1472
Positioning Problem	6	6
Loose or Intermittent Connection	5	5
Fracture	5	406
Degraded	5	5
Defective Device	5	5
Difficult to Insert	4	4
Inadequacy of Device Shape and/or Size	4	4
Positioning Failure	3	3
Physical Resistance/Sticking	3	3
Naturally Worn	3	3
Compatibility Problem	3	3
Patient-Device Incompatibility	2	2
No Apparent Adverse Event	2	2
Appropriate Term/Code Not Available	2	2
Device-Device Incompatibility	2	2
Improper or Incorrect Procedure or Method	2	403
Unstable	2	2
Scratched Material	1	1
Difficult to Remove	1	1
Unsealed Device Packaging	1	1
Use of Device Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Device Damaged by Another Device	1	1
Misconnection	1	1
Delivered as Unsterile Product	1	1
Crack	1	1
Device Markings/Labelling Problem	1	1
Off-Label Use	1	1
Inaccurate Information	1	1
Nonstandard Device	1	1
Premature Separation	1	1
Device Contaminated During Manufacture or Shipping	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	97	1563
Joint Dislocation	80	1554
No Clinical Signs, Symptoms or Conditions	64	64
Failure of Implant	49	52
Injury	41	42
Pain	39	441
Insufficient Information	35	1503
Metal Related Pathology	33	436
Bone Fracture(s)	23	1088
Osteolysis	21	426
No Known Impact Or Consequence To Patient	21	21
Inadequate Osseointegration	18	19
Joint Laxity	17	416
Hip Fracture	11	12
Arthralgia	11	11
Fall	11	11
Deformity/ Disfigurement	10	1479
Bacterial Infection	10	10
Swelling/ Edema	7	7
Subluxation	7	7
Ambulation Difficulties	6	7
Implant Pain	6	6
Inflammation	5	5
Foreign Body Reaction	5	5
Infiltration into Tissue	4	4
Muscle/Tendon Damage	4	4
Loss of Range of Motion	4	5
Post Operative Wound Infection	4	4
Impaired Healing	4	4
No Information	4	4
Solid Tumour	4	405
Ossification	3	404
Ischemic Heart Disease	3	3
Thrombosis/Thrombus	3	3
Nerve Damage	3	3
Synovitis	3	404
Discomfort	3	3
Unequal Limb Length	3	404
Sepsis	3	3
Purulent Discharge	2	2
Anemia	2	2
Fever	2	3
No Consequences Or Impact To Patient	2	2
Hematoma	2	2
Wound Dehiscence	2	2
Scar Tissue	2	2
Failure to Anastomose	2	2
Unspecified Tissue Injury	2	2
External Prosthetic Device Pain	1	1
Tissue Breakdown	1	1

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