TPLC - Total Product Life Cycle

• Device: prosthesis, hip, hemi-, trunnion-bearing, femoral, metal/polyacetal
• Product Code: JDH
• Regulation Number: 888.3380
• Device Class: 3

MDR Year	MDR Reports	MDR Events
2017	82	82
2018	223	223
2019	354	354
2020	292	292
2021	158	158
2022	76	76
2023	5	5
2024	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	364	364
Adverse Event Without Identified Device or Use Problem	281	281
Device Dislodged or Dislocated	116	116
Break	81	81
Fracture	70	70
Loosening of Implant Not Related to Bone-Ingrowth	49	49
Naturally Worn	42	42
Loose or Intermittent Connection	39	39
Appropriate Term/Code Not Available	23	23
Unintended Movement	22	22
Biocompatibility	20	20
Unstable	15	15
Corroded	14	14
Degraded	11	11
Material Deformation	9	9
Patient Device Interaction Problem	8	8
Migration or Expulsion of Device	8	8
Detachment Of Device Component	7	7
Loss of Osseointegration	7	7
Compatibility Problem	7	7
Material Integrity Problem	6	6
Metal Shedding Debris	6	6
Material Separation	4	4
Malposition of Device	4	4
Connection Problem	4	4
Migration	4	4
Noise, Audible	3	3
Incomplete or Inadequate Connection	3	3
Material Erosion	3	3
Device Damaged by Another Device	3	3
Mechanical Jam	3	3
Activation, Positioning or Separation Problem	3	3
Fitting Problem	3	3
Crack	3	3
Misassembled	3	3
Pitted	3	3
Mechanical Problem	3	3
Off-Label Use	2	2
Inadequacy of Device Shape and/or Size	2	2
Separation Failure	2	2
Osseointegration Problem	2	2
Contamination /Decontamination Problem	2	2
Material Twisted/Bent	1	1
Device Contamination with Chemical or Other Material	1	1
Positioning Problem	1	1
Device Handling Problem	1	1
Illegible Information	1	1
Unclear Information	1	1
Physical Resistance/Sticking	1	1
Patient-Device Incompatibility	1	1
Detachment of Device or Device Component	1	1
Device Operates Differently Than Expected	1	1
Use of Device Problem	1	1
Component Missing	1	1
Dull, Blunt	1	1
Failure to Osseointegrate	1	1
Material Rupture	1	1
Material Fragmentation	1	1
Difficult to Insert	1	1
Positioning Failure	1	1
Failure to Convert to Back-Up	1	1
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Injury	525	525
Unspecified Infection	138	138
Joint Dislocation	104	104
Pain	99	99
No Clinical Signs, Symptoms or Conditions	95	95
Failure of Implant	79	79
Bone Fracture(s)	76	76
Metal Related Pathology	41	41
No Information	39	39
No Known Impact Or Consequence To Patient	35	35
No Consequences Or Impact To Patient	32	32
Hip Fracture	19	19
Osteolysis	15	15
No Code Available	14	14
Inadequate Osseointegration	12	12
Thrombosis/Thrombus	10	10
Insufficient Information	10	10
Test Result	8	8
Ambulation Difficulties	8	8
Loss of Range of Motion	8	8
Necrosis	8	8
Inflammation	5	5
Discomfort	5	5
Implant Pain	5	5
Swelling/ Edema	4	4
Subluxation	4	4
Joint Laxity	4	4
Neuralgia	3	3
Unequal Limb Length	3	3
Joint Disorder	3	3
Foreign Body In Patient	3	3
Toxicity	3	3
Thrombosis	3	3
Ossification	3	3
Bacterial Infection	2	2
Cyst(s)	2	2
Death	2	2
Muscular Rigidity	2	2
Hemorrhage/Bleeding	2	2
Scar Tissue	2	2
Non-union Bone Fracture	2	2
Arthralgia	2	2
Tissue Breakdown	2	2
Post Operative Wound Infection	2	2
No Patient Involvement	1	1
Impaired Healing	1	1
Reaction	1	1
Osteopenia/ Osteoporosis	1	1
Thromboembolism	1	1
Limited Mobility Of The Implanted Joint	1	1
Unspecified Musculoskeletal problem	1	1
Skin Infection	1	1
Cardiovascular Insufficiency	1	1
Unspecified Heart Problem	1	1
Muscle/Tendon Damage	1	1
Deformity/ Disfigurement	1	1
Disability	1	1
Sepsis	1	1
Swelling	1	1
Synovitis	1	1
Tachycardia	1	1
Tissue Damage	1	1
Ventricular Fibrillation	1	1
Hernia	1	1
Wheal(s)	1	1
Infiltration into Tissue	1	1
Laceration(s)	1	1
Muscle Weakness	1	1
Debris, Bone Shedding	1	1
Fall	1	1
Fistula	1	1
Foreign Body Sensation in Eye	1	1
Chest Pain	1	1
Hematoma	1	1