TPLC - Total Product Life Cycle

• Device: prosthesis, hip, semi-constrained (metal uncemented acetabular component)
• Product Code: KWA
• Regulation Number: 888.3330
• Device Class: 3

MDR Year	MDR Reports	MDR Events
2018	6391	6391
2019	7630	7630
2020	4537	4537
2021	2066	2066
2022	1620	1620
2023	1482	1482
2024	1168	1171

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	9639	9639
Insufficient Information	3321	3321
Naturally Worn	2524	2524
Device Dislodged or Dislocated	2380	2380
Loss of Osseointegration	1201	1201
Appropriate Term/Code Not Available	1105	1105
Material Erosion	869	869
Fracture	798	798
Osseointegration Problem	688	688
Corroded	653	653
Device Contaminated During Manufacture or Shipping	562	562
Migration	552	555
Noise, Audible	429	429
Malposition of Device	382	382
Biocompatibility	375	375
Use of Device Problem	373	373
Material Disintegration	274	274
Loosening of Implant Not Related to Bone-Ingrowth	266	266
Degraded	244	244
Migration or Expulsion of Device	243	243
Packaging Problem	237	237
Nonstandard Device	235	235
Loss of or Failure to Bond	191	191
Loose or Intermittent Connection	182	182
Unstable	175	175
Tear, Rip or Hole in Device Packaging	175	175
Patient Device Interaction Problem	173	173
Metal Shedding Debris	163	163
Difficult to Insert	157	157
Break	148	148
Manufacturing, Packaging or Shipping Problem	131	131
Difficult to Remove	98	98
Detachment of Device or Device Component	86	86
Patient-Device Incompatibility	81	81
Inadequacy of Device Shape and/or Size	81	81
Separation Failure	79	79
Device-Device Incompatibility	75	75
Unintended Movement	68	68
Disassembly	58	58
Device Packaging Compromised	58	58
Failure to Osseointegrate	57	57
Positioning Failure	53	53
No Apparent Adverse Event	48	48
Separation Problem	40	40
Device Contamination with Chemical or Other Material	36	36
Off-Label Use	34	34
Fitting Problem	31	31
Material Deformation	29	29
Delivered as Unsterile Product	28	28
Material Integrity Problem	24	24

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	10429	10430
No Code Available	9472	9474
Foreign Body Reaction	3532	3532
Test Result	3015	3015
Unspecified Infection	2740	2741
Tissue Damage	2121	2121
Joint Dislocation	1910	1910
Osteolysis	1893	1893
Discomfort	1877	1877
Injury	1680	1680
Inadequate Osseointegration	1622	1623
Metal Related Pathology	1579	1579
Hypersensitivity/Allergic reaction	1428	1428
No Information	1398	1398
Not Applicable	1368	1368
Limited Mobility Of The Implanted Joint	1204	1204
Reaction	1099	1099
Inflammation	1003	1003
Bone Fracture(s)	971	971
Loss of Range of Motion	917	917
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	877	877
Distress	831	831
Ambulation Difficulties	701	701
Necrosis	680	680
No Clinical Signs, Symptoms or Conditions	678	678
Insufficient Information	623	623
Host-Tissue Reaction	614	614
Edema	584	584
Failure of Implant	541	541
Swelling/ Edema	520	520
No Patient Involvement	503	503
Adhesion(s)	486	486
Unspecified Tissue Injury	462	462
No Consequences Or Impact To Patient	428	428
No Known Impact Or Consequence To Patient	424	424
Weakness	420	420
Synovitis	367	367
Swelling	367	367
Deformity/ Disfigurement	366	366
Anxiety	358	358
Cyst(s)	341	341
Scar Tissue	337	337
Joint Laxity	298	298
Fatigue	286	286
Fall	251	251
Local Reaction	239	239
Ossification	213	213
Hematoma	202	202
Muscular Rigidity	196	196
Thrombosis	166	166

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
6	Zimmer Biomet, Inc.	II	Dec-19-2018
7	Zimmer Biomet, Inc.	II	Aug-14-2018