TPLC - Total Product Life Cycle

• Device: prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
• Product Code: MEH
• Regulation Number: 888.3353
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
CONFORMIS INC
	SUBSTANTIALLY EQUIVALENT	1
CONFORMIS INC.
	SUBSTANTIALLY EQUIVALENT	1
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	2
DEPUY ORTHOPAEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
IMPLANTCAST GMBH
	SUBSTANTIALLY EQUIVALENT	1
IMPLANTCAST, GMBH
	SUBSTANTIALLY EQUIVALENT	1
ORTHO DEVELOPMENT CORP.
	SUBSTANTIALLY EQUIVALENT	1
SIGNATURE ORTHOPAEDICS PTY LTD.
	SUBSTANTIALLY EQUIVALENT	4
STRYKER
	SUBSTANTIALLY EQUIVALENT	1
STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	341	341
2020	337	337
2021	372	372
2022	316	316
2023	335	335
2024	172	172

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	530	530
Device-Device Incompatibility	308	308
Insufficient Information	285	285
Device Dislodged or Dislocated	179	179
Appropriate Term/Code Not Available	152	152
Break	96	96
Osseointegration Problem	70	70
Fracture	59	59
Detachment of Device or Device Component	48	48
Degraded	47	47
Loose or Intermittent Connection	36	36
Loosening of Implant Not Related to Bone-Ingrowth	36	36
Migration	35	35
Material Erosion	35	35
Corroded	23	23
Device Appears to Trigger Rejection	22	22
Unstable	22	22
Device Contaminated During Manufacture or Shipping	21	21
Tear, Rip or Hole in Device Packaging	16	16
Loss of Osseointegration	14	14
Malposition of Device	14	14
Naturally Worn	13	13
Inadequacy of Device Shape and/or Size	8	8
Use of Device Problem	7	7
Failure to Cut	7	7
Patient-Device Incompatibility	6	6
Material Deformation	6	6
Unintended Movement	6	6
Mechanical Problem	6	6
Noise, Audible	6	6
Inaccurate Information	6	6
Migration or Expulsion of Device	5	5
Difficult to Insert	4	4
Off-Label Use	4	4
Defective Device	4	4
Patient Device Interaction Problem	4	4
Material Integrity Problem	3	3
Compatibility Problem	3	3
Positioning Problem	3	3
Component Missing	3	3
Difficult to Remove	3	3
Nonstandard Device	3	3
Delivered as Unsterile Product	2	2
Incomplete or Missing Packaging	2	2
Material Fragmentation	2	2
Mechanical Jam	2	2
Manufacturing, Packaging or Shipping Problem	2	2
No Apparent Adverse Event	2	2
Calibration Problem	2	2
Connection Problem	1	1
Data Back-Up Problem	1	1
Device Markings/Labelling Problem	1	1
Device Damaged by Another Device	1	1
Deformation Due to Compressive Stress	1	1
Material Protrusion/Extrusion	1	1
Material Twisted/Bent	1	1
Device Contamination with Chemical or Other Material	1	1
Difficult to Open or Remove Packaging Material	1	1
Device Handling Problem	1	1
Separation Problem	1	1
Difficult or Delayed Separation	1	1
Scratched Material	1	1
Therapeutic or Diagnostic Output Failure	1	1
Packaging Problem	1	1
Misconnection	1	1
Crack	1	1
Collapse	1	1
Difficult or Delayed Positioning	1	1
Positioning Failure	1	1
Entrapment of Device	1	1
Failure to Align	1	1
Expiration Date Error	1	1
Peeled/Delaminated	1	1
Material Separation	1	1
Failure to Osseointegrate	1	1
Fitting Problem	1	1
Device Damaged Prior to Use	1	1
Microbial Contamination of Device	1	1
Wrong Label	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	334	334
Pain	316	316
Injury	214	214
Metal Related Pathology	148	148
Joint Dislocation	142	142
Inflammation	142	142
Insufficient Information	136	136
Foreign Body Reaction	131	131
No Clinical Signs, Symptoms or Conditions	129	129
Limb Fracture	106	106
Reaction	95	95
Inadequate Osseointegration	86	86
Failure of Implant	74	74
Bone Fracture(s)	67	67
Fall	65	65
Ambulation Difficulties	64	64
No Consequences Or Impact To Patient	49	49
No Known Impact Or Consequence To Patient	40	40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	37	37
Joint Laxity	32	32
Osteolysis	31	31
No Code Available	24	24
No Patient Involvement	21	21
Joint Disorder	16	16
Local Reaction	14	14
Implant Pain	14	14
Discomfort	13	13
Hip Fracture	13	13
Loss of Range of Motion	12	12
Bacterial Infection	12	12
Physical Asymmetry	11	11
No Information	11	11
Swelling/ Edema	10	10
Muscle/Tendon Damage	10	10
Unequal Limb Length	10	10
Necrosis	9	9
Hematoma	9	9
Wound Dehiscence	7	7
Ossification	6	6
Unspecified Tissue Injury	6	6
Heart Failure/Congestive Heart Failure	5	5
Host-Tissue Reaction	5	5
Hemorrhage/Bleeding	5	5
Deformity/ Disfigurement	5	5
Tissue Damage	5	5
Nerve Damage	4	4
Cyst(s)	4	4
Fluid Discharge	4	4
Foreign Body In Patient	4	4
Patient Problem/Medical Problem	3	3
Osteopenia/ Osteoporosis	3	3
Limited Mobility Of The Implanted Joint	3	3
Thrombosis/Thrombus	3	3
Abscess	3	3
Hypersensitivity/Allergic reaction	3	3
Erythema	3	3
Synovitis	3	3
Toxicity	3	3
Arthralgia	3	3
Numbness	3	3
Distress	2	2
Weakness	2	2
Swelling	2	2
Sepsis	2	2
Seroma	2	2
Fatigue	2	2
Neuropathy	2	2
Menstrual Irregularities	2	2
Muscular Rigidity	2	2
Purulent Discharge	2	2
Cardiomyopathy	2	2
Cellulitis	2	2
Granuloma	2	2
Post Operative Wound Infection	2	2
Test Result	1	1
Device Embedded In Tissue or Plaque	1	1
Pericarditis	1	1
Cancer	1	1
Paresthesia	1	1
Embolism/Embolus	1	1
Unspecified Musculoskeletal problem	1	1
Localized Skin Lesion	1	1
Malunion of Bone	1	1
Headache	1	1
Adhesion(s)	1	1
Erosion	1	1
Pulmonary Embolism	1	1
Paralysis	1	1
Muscle Weakness	1	1
Flashers	1	1
Irritation	1	1
Skin Discoloration	1	1
Scar Tissue	1	1
Loss of Vision	1	1
Burning Sensation	1	1
Rupture	1	1
Discharge	1	1
Anxiety	1	1
Non-union Bone Fracture	1	1
Scar Excision	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Biomet, Inc.	II	Dec-17-2020
2	Corin Ltd	II	Sep-30-2021
3	Corin Ltd	II	Jun-11-2021
4	Corin Ltd	II	Mar-22-2021
5	Exactech, Inc.	II	Sep-09-2022
6	Signature Orthopaedics Europe Ltd	II	Mar-25-2020
7	Signature Orthopedics Pty Limited	II	May-28-2021
8	Waldemar Link GmbH & Co. KG (Mfg Site)	II	Jan-11-2019