TPLC - Total Product Life Cycle

• Device: prosthesis, hip, semi-constrained (metal uncemented acetabular component)
• Regulation Description: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
• Product Code: KWA
• Regulation Number: 888.3330
• Device Class: 3

MDR Year	MDR Reports	MDR Events
2020	4537	4537
2021	2066	2066
2022	1620	1620
2023	1482	1482
2024	1167	1170
2025	292	292

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	5510	5510
Device Dislodged or Dislocated	1031	1031
Naturally Worn	872	872
Insufficient Information	467	467
Device Contaminated During Manufacture or Shipping	454	454
Fracture	398	398
Material Erosion	387	387
Osseointegration Problem	337	337
Loss of Osseointegration	319	319
Migration	256	259
Corroded	206	206
Packaging Problem	194	194
Loosening of Implant Not Related to Bone-Ingrowth	186	186
Noise, Audible	180	180
Manufacturing, Packaging or Shipping Problem	180	180
Use of Device Problem	167	167
Patient Device Interaction Problem	166	166
Appropriate Term/Code Not Available	155	155
Tear, Rip or Hole in Device Packaging	128	128
Malposition of Device	126	126
Degraded	122	122
Difficult to Insert	119	119
Biocompatibility	87	87
Unstable	65	65
Patient-Device Incompatibility	63	63
Material Disintegration	54	54
Loss of or Failure to Bond	50	50
Detachment of Device or Device Component	48	48
Unintended Movement	41	41
Positioning Failure	38	38
Difficult to Remove	37	37
Inadequacy of Device Shape and/or Size	36	36
Device-Device Incompatibility	30	30
Separation Failure	28	28
Off-Label Use	28	28
Break	28	28
Material Integrity Problem	21	21
Nonstandard Device	21	21
No Apparent Adverse Event	17	17
Delivered as Unsterile Product	17	17
Mechanical Problem	15	15
Loose or Intermittent Connection	10	10
Improper or Incorrect Procedure or Method	10	10
Physical Resistance/Sticking	10	10
Failure to Osseointegrate	9	9
Material Deformation	9	9
Illegible Information	8	8
Inaccurate Information	7	7
Unsealed Device Packaging	7	7
Output Problem	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	4211	4211
No Code Available	2785	2785
Foreign Body Reaction	2038	2038
Metal Related Pathology	1504	1504
Unspecified Infection	1074	1074
Osteolysis	849	849
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	817	817
Hypersensitivity/Allergic reaction	816	816
Joint Dislocation	798	798
No Clinical Signs, Symptoms or Conditions	791	791
Test Result	677	677
Insufficient Information	640	640
Discomfort	608	608
Inadequate Osseointegration	565	565
Swelling/ Edema	485	485
Failure of Implant	450	450
Unspecified Tissue Injury	420	420
Distress	405	405
Bone Fracture(s)	400	400
Ambulation Difficulties	394	394
Loss of Range of Motion	376	376
Inflammation	310	310
Joint Laxity	294	294
No Patient Involvement	293	293
Necrosis	293	293
Adhesion(s)	283	283
No Information	280	280
Edema	251	251
No Known Impact Or Consequence To Patient	234	234
Synovitis	229	229
Deformity/ Disfigurement	226	226
Limited Mobility Of The Implanted Joint	222	222
Scar Tissue	201	201
Tissue Damage	182	182
Fall	179	179
Fatigue	170	170
Cyst(s)	161	161
Anxiety	157	157
Reaction	145	145
Injury	144	144
Muscle/Tendon Damage	133	133
Ossification	115	115
Local Reaction	109	109
Physical Asymmetry	108	108
Muscular Rigidity	107	107
Depression	85	85
Hematoma	79	79
Hemorrhage/Bleeding	78	78
Weakness	74	74
Osteopenia/ Osteoporosis	69	69

Recalls
Manufacturer		Recall Class	Date Posted
1	Biomet, Inc.	II	Nov-21-2023
2	Biomet, Inc.	II	Aug-12-2021
3	DePuy Orthopaedics, Inc.	II	Jan-07-2021
4	Encore Medical, LP	II	Sep-19-2023