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
2019	7628	7644
2020	4538	4543
2021	2064	2067
2022	1616	1617
2023	1475	1475
2024	1167	1170
2025	994	1051

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	8840	8899
Device Dislodged or Dislocated	1991	1993
Naturally Worn	1943	1943
Insufficient Information	1060	1060
Loss of Osseointegration	1037	1037
Fracture	673	676
Osseointegration Problem	655	655
Material Erosion	636	636
Device Contaminated During Manufacture or Shipping	524	524
Migration	497	500
Corroded	428	433
Use of Device Problem	379	379
Biocompatibility	329	329
Noise, Audible	324	327
Malposition of Device	295	295
Packaging Problem	269	269
Tear, Rip or Hole in Device Packaging	265	265
Loosening of Implant Not Related to Bone-Ingrowth	261	264
Manufacturing, Packaging or Shipping Problem	223	223
Appropriate Term/Code Not Available	215	219
Degraded	213	213
Patient Device Interaction Problem	173	173
Loss of or Failure to Bond	169	169
Nonstandard Device	154	154
Difficult to Insert	150	150
Material Disintegration	141	142
Unstable	117	117
Break	93	96
Delivered as Unsterile Product	77	77
Patient-Device Incompatibility	74	82
Detachment of Device or Device Component	72	72
Inadequacy of Device Shape and/or Size	69	69
Difficult to Remove	68	68
Unintended Movement	66	66
Device-Device Incompatibility	61	61
Positioning Failure	57	57
Loose or Intermittent Connection	51	51
Separation Failure	42	42
No Apparent Adverse Event	37	37
Off-Label Use	34	34
Failure to Osseointegrate	34	34
Migration or Expulsion of Device	30	33
Separation Problem	22	22
Material Integrity Problem	22	22
Mechanical Problem	20	21
Material Deformation	17	17
Mechanical Jam	15	15
Material Twisted/Bent	14	14
Positioning Problem	14	14
Fitting Problem	13	13

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Code Available	7826	7833
Pain	7638	7658
Foreign Body Reaction	3171	3171
Unspecified Infection	2274	2291
Test Result	2242	2248
Metal Related Pathology	1664	1667
Osteolysis	1571	1571
Joint Dislocation	1559	1560
Inadequate Osseointegration	1345	1345
Tissue Damage	1287	1287
Hypersensitivity/Allergic reaction	1264	1264
Discomfort	1171	1174
No Clinical Signs, Symptoms or Conditions	1039	1040
Injury	844	844
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	837	838
Bone Fracture(s)	779	780
No Information	740	740
Limited Mobility Of The Implanted Joint	729	729
Insufficient Information	703	707
Loss of Range of Motion	662	662
Inflammation	624	627
Necrosis	545	546
Ambulation Difficulties	537	540
Failure of Implant	531	538
Swelling/ Edema	526	526
Distress	477	477
Reaction	470	470
Edema	463	467
Unspecified Tissue Injury	456	456
Adhesion(s)	384	384
No Patient Involvement	375	375
No Known Impact Or Consequence To Patient	335	335
Joint Laxity	325	325
Synovitis	301	302
Scar Tissue	291	291
Deformity/ Disfigurement	270	270
Cyst(s)	243	243
Fatigue	239	243
Anxiety	232	233
No Consequences Or Impact To Patient	226	226
Fall	216	218
Swelling	208	209
Weakness	199	203
Not Applicable	186	186
Local Reaction	185	185
Host-Tissue Reaction	177	177
Ossification	170	170
Hematoma	148	148
Thrombosis	143	143
Muscle/Tendon Damage	143	143

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
5	Zimmer Biomet, Inc.	II	Nov-07-2019