TPLC - Total Product Life Cycle

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Device	prosthesis, hip, hemi-, femoral, metal
Regulation Description	Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
Product Code	KWL
Regulation Number	888.3360
Device Class	2

Premarket Reviews
Manufacturer	Decision
BIOCOMPOSITES, LTD.
	SUBSTANTIALLY EQUIVALENT	1
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	1
HERAEUS MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	1
1. K234028 COPAL® exchange G hip spacer; COPAL® G+V
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
OSTEOREMEDIES, LLC
	SUBSTANTIALLY EQUIVALENT	2
TECRES S.P.A.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	108	110
Biocompatibility	106	123
Loss of Osseointegration	61	61
Device Dislodged or Dislocated	36	36
Insufficient Device Problem Information	33	38
Break	18	18
Tear, Rip or Hole in Device Packaging	12	12
Device Contaminated During Manufacture or Shipping	11	11
Packaging Problem	10	10
Detachment of Device or Device Component	10	10
Fracture	10	10
Naturally Worn	9	10
Osseointegration Problem	8	8
Computer System Security Problem	7	7
Unstable	4	4
Corroded	4	4
Malposition of Device	3	3
Loosening of Implant Not Related to Bone-Ingrowth	3	3
Failure to Osseointegrate	3	3
Material Deformation	3	3
Patient-Device Incompatibility	2	2
Unintended Movement	2	2
Unsealed Device Packaging	2	2
Patient Device Interaction Problem	2	2
Degraded	2	3
No Apparent Adverse Event	2	2
Loss of or Failure to Bond	2	2
Device-Device Incompatibility	1	1
Separation Problem	1	1
Off-Label Use	1	1
Device Markings/Labelling Problem	1	1
Material Integrity Problem	1	1
Difficult to Insert	1	1
Use of Device Problem	1	1
Failure to Align	1	1
Loose or Intermittent Connection	1	1
Mechanical Jam	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	116	123
Metal Related Pathology	113	128
Pain	74	82
Unspecified Infection	53	54
No Clinical Signs, Symptoms or Conditions	43	43
Joint Dislocation	42	42
Failure of Implant	22	24
Osteolysis	16	20
High metal ion levels	15	20
Infiltration into Tissue	15	18
Bone Fracture(s)	15	15
Inadequate Osseointegration	13	13
Leiomyosarcoma	11	11
Arthralgia	11	13
Loss of Range of Motion	10	13
Ambulation or Postural Difficulties	9	12
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	7	7
Joint Laxity	6	7
Limb Fracture	6	6
Implant Pain	5	5
Necrosis	5	5
Synovitis	4	5
Swelling/ Edema	4	4
Fall	4	4
Hematoma	3	3
Inflammation	3	4
Medical device site infection	3	4
Foreign Body Reaction	3	3
Discomfort	3	3
Solid Tumour	3	5
Muscle Weakness/Atrophy	2	2
Wound Dehiscence	2	2
Cramp(s) /Muscle Spasm(s)	2	2
No Known Impact Or Consequence To Patient	2	2
Extraskeletal ossification	2	2
Tinnitus	2	2
Headache	2	2
Bacterial Infection	2	2
No Patient Involvement	2	2
Unspecified Eye / Vision Problem	2	2
Muscle/Tendon Damage	2	2
Hip Fracture	2	2
Fluid Discharge	2	2
Distress	1	2
Fistula	1	1
Skin Infection	1	1
No Consequences Or Impact To Patient	1	1
Hypersensitivity/Allergic reaction	1	1
Erosion	1	2
Unspecified Tissue Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Howmedica Osteonics Corp.	II	Jul-16-2024