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	340	340
2020	337	337
2021	372	372
2022	316	316
2023	334	334
2024	112	112

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	500	500
Device-Device Incompatibility	298	298
Insufficient Information	282	282
Device Dislodged or Dislocated	174	174
Appropriate Term/Code Not Available	149	149
Break	96	96
Osseointegration Problem	68	68
Fracture	58	58
Detachment of Device or Device Component	47	47
Degraded	43	43
Loose or Intermittent Connection	36	36
Material Erosion	35	35
Loosening of Implant Not Related to Bone-Ingrowth	34	34
Migration	34	34
Corroded	22	22
Unstable	22	22
Device Contaminated During Manufacture or Shipping	21	21
Device Appears to Trigger Rejection	18	18
Tear, Rip or Hole in Device Packaging	15	15
Loss of Osseointegration	14	14
Malposition of Device	14	14
Naturally Worn	13	13
Inadequacy of Device Shape and/or Size	8	8
Failure to Cut	7	7
Patient-Device Incompatibility	6	6
Material Deformation	6	6
Unintended Movement	6	6
Use of Device Problem	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
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
Patient Device Interaction Problem	3	3
Delivered as Unsterile Product	2	2
Material Fragmentation	2	2
Mechanical Jam	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
Manufacturing, Packaging or Shipping Problem	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
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
Incomplete or Missing Packaging	1	1
Failure to Align	1	1
Expiration Date Error	1	1
Wrong Label	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	318	318
Pain	310	310
Injury	213	213
Inflammation	142	142
Metal Related Pathology	142	142
Joint Dislocation	138	138
Insufficient Information	129	129
Foreign Body Reaction	127	127
No Clinical Signs, Symptoms or Conditions	124	124
Limb Fracture	97	97
Reaction	95	95
Inadequate Osseointegration	83	83
Failure of Implant	73	73
Bone Fracture(s)	65	65
Fall	64	64
Ambulation Difficulties	61	61
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	36	36
Joint Laxity	31	31
Osteolysis	29	29
No Code Available	24	24
No Patient Involvement	21	21
Joint Disorder	16	16
Local Reaction	14	14
Discomfort	13	13
Hip Fracture	13	13
Loss of Range of Motion	12	12
Bacterial Infection	12	12
Implant Pain	12	12
Physical Asymmetry	11	11
No Information	11	11
Swelling/ Edema	10	10
Muscle/Tendon Damage	10	10
Unequal Limb Length	9	9
Necrosis	9	9
Hematoma	9	9
Wound Dehiscence	6	6
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
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
Thrombosis/Thrombus	2	2
Pericarditis	1	1
Cancer	1	1
Paresthesia	1	1
Embolism/Embolus	1	1
Test Result	1	1
Device Embedded In Tissue or Plaque	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