TPLC - Total Product Life Cycle

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Device	prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
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	242	242
Insufficient Information	108	108
Device Dislodged or Dislocated	55	55
Connection Problem	28	28
Biocompatibility	20	20
Fitting Problem	16	16
Loose or Intermittent Connection	15	15
Unstable	13	13
Incomplete or Inadequate Connection	10	10
Unintended Movement	10	10
Break	8	8
Migration	8	8
Loss of Osseointegration	7	7
Loosening of Implant Not Related to Bone-Ingrowth	7	7
Failure to Align	7	7
Positioning Problem	6	6
Defective Device	5	5
Patient Device Interaction Problem	5	5
Failure to Osseointegrate	5	5
Inadequacy of Device Shape and/or Size	5	5
Osseointegration Problem	4	4
Malposition of Device	4	4
Physical Resistance/Sticking	4	4
Appropriate Term/Code Not Available	4	4
Fracture	4	4
Degraded	4	4
Difficult to Insert	4	4
Compatibility Problem	3	3
Migration or Expulsion of Device	3	3
Naturally Worn	3	3
Positioning Failure	3	3
Flaked	2	2
Nonstandard Device	2	2
No Apparent Adverse Event	2	2
Misconnection	2	2
Patient-Device Incompatibility	2	2
Device-Device Incompatibility	2	2
Misassembled	1	1
Delivered as Unsterile Product	1	1
Calibration Problem	1	1
Device Damaged by Another Device	1	1
Use of Device Problem	1	1
Scratched Material	1	1
Illegible Information	1	1
Difficult to Remove	1	1
Therapeutic or Diagnostic Output Failure	1	1
Material Integrity Problem	1	1
Unsealed Device Packaging	1	1
Device Markings/Labelling Problem	1	1
Inaccurate Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Injury	123	123
Unspecified Infection	111	111
Joint Dislocation	94	94
No Clinical Signs, Symptoms or Conditions	63	63
Pain	56	56
Failure of Implant	48	48
Metal Related Pathology	31	31
No Known Impact Or Consequence To Patient	27	27
Insufficient Information	26	26
Osteolysis	19	19
No Consequences Or Impact To Patient	17	17
Inadequate Osseointegration	16	16
Bone Fracture(s)	16	16
Hip Fracture	11	11
Joint Laxity	11	11
Fall	11	11
Bacterial Infection	10	10
Arthralgia	9	9
Subluxation	7	7
Ambulation Difficulties	5	5
Deformity/ Disfigurement	5	5
Inflammation	5	5
Implant Pain	5	5
Foreign Body Reaction	5	5
Impaired Healing	4	4
Infiltration into Tissue	4	4
Swelling/ Edema	4	4
No Information	4	4
Muscle/Tendon Damage	4	4
Post Operative Wound Infection	4	4
Discomfort	4	4
Loss of Range of Motion	4	4
Sepsis	3	3
Ischemic Heart Disease	3	3
Nerve Damage	3	3
Unspecified Tissue Injury	2	2
Failure to Anastomose	2	2
Scar Tissue	2	2
Unequal Limb Length	2	2
Thrombosis/Thrombus	2	2
Fever	2	2
Local Reaction	2	2
Purulent Discharge	2	2
Synovitis	2	2
Hematoma	2	2
Solid Tumour	2	2
Wound Dehiscence	2	2
Osteomyelitis	1	1
Muscular Rigidity	1	1
Foreign Body In Patient	1	1

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