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

Premarket Reviews
Manufacturer	Decision
MICROPORT ORTHOPEDICS INC.
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	7
WRIGHT MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	284	284
Insufficient Information	179	179
Device Dislodged or Dislocated	122	122
Connection Problem	37	37
Loose or Intermittent Connection	36	36
Appropriate Term/Code Not Available	23	23
Fitting Problem	21	21
Unintended Movement	21	21
Biocompatibility	20	20
Unstable	18	18
Break	15	15
Device Slipped	10	10
Positioning Problem	10	10
Incomplete or Inadequate Connection	10	10
Fracture	10	10
Loss of Osseointegration	8	8
Difficult to Insert	8	8
Migration	8	8
Failure to Align	8	8
Malposition of Device	8	8
Migration or Expulsion of Device	8	8
Loosening of Implant Not Related to Bone-Ingrowth	7	7
Inadequacy of Device Shape and/or Size	6	6
Device Operates Differently Than Expected	6	6
Failure to Osseointegrate	5	5
Degraded	5	5
Patient Device Interaction Problem	5	5
Osseointegration Problem	5	5
Naturally Worn	5	5
Defective Device	5	5
Mechanical Problem	4	4
Physical Resistance/Sticking	4	4
No Apparent Adverse Event	3	3
Positioning Failure	3	3
Device-Device Incompatibility	3	3
Misconnection	3	3
Compatibility Problem	3	3
Nonstandard Device	3	3
Difficult to Remove	3	3
Patient-Device Incompatibility	3	3
Off-Label Use	2	2
High Test Results	2	2
Flaked	2	2
Improper or Incorrect Procedure or Method	2	2
Dull, Blunt	1	1
Detachment Of Device Component	1	1
Leak/Splash	1	1
Device Contaminated During Manufacture or Shipping	1	1
Device Damaged by Another Device	1	1
Disconnection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Injury	190	190
Unspecified Infection	148	148
Joint Dislocation	139	139
Pain	84	85
Failure of Implant	73	73
No Code Available	67	67
No Clinical Signs, Symptoms or Conditions	63	63
No Known Impact Or Consequence To Patient	53	53
Metal Related Pathology	31	31
Insufficient Information	26	26
Osteolysis	21	21
No Consequences Or Impact To Patient	20	20
No Information	20	20
Bone Fracture(s)	19	19
Inadequate Osseointegration	17	17
Fall	15	15
Hip Fracture	14	14
Bacterial Infection	11	11
Joint Laxity	11	11
Arthralgia	9	9
Inflammation	8	8
Ambulation Difficulties	7	7
Subluxation	7	7
Toxicity	6	6
Loss of Range of Motion	6	6
Post Operative Wound Infection	6	6
Deformity/ Disfigurement	5	5
Discomfort	5	5
Foreign Body In Patient	5	5
Foreign Body Reaction	5	5
Implant Pain	5	5
Limited Mobility Of The Implanted Joint	5	5
Impaired Healing	4	4
Infiltration into Tissue	4	4
Sepsis	4	4
Muscle/Tendon Damage	4	4
Swelling/ Edema	4	4
Purulent Discharge	3	3
Ischemic Heart Disease	3	3
Fever	3	3
Nerve Damage	3	3
Synovitis	2	2
Hematoma	2	2
Patch Test, Abnormal Results Of	2	2
Local Reaction	2	2
Device Embedded In Tissue or Plaque	2	2
Low Blood Pressure/ Hypotension	2	2
Thrombosis/Thrombus	2	2
Test Result	2	2
Swelling	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	MicroPort Orthopedics, Inc.	I	Sep-28-2015
2	Ortho Development Corporation	II	Jun-20-2011
3	Smith & Nephew Inc	II	Feb-21-2014
4	Smith & Nephew Inc	II	Aug-08-2013
5	Smith & Nephew, Inc.	II	Jun-09-2020