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
2019	7632	7632
2020	4537	4537
2021	2065	2065
2022	1620	1620
2023	1482	1482
2024	966	969

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	8356	8356
Device Dislodged or Dislocated	1932	1932
Naturally Worn	1908	1908
Insufficient Information	1040	1040
Loss of Osseointegration	1035	1035
Fracture	628	628
Osseointegration Problem	625	625
Material Erosion	550	550
Device Contaminated During Manufacture or Shipping	520	520
Migration	481	484
Corroded	424	424
Use of Device Problem	364	364
Biocompatibility	326	326
Noise, Audible	316	316
Malposition of Device	292	292
Loosening of Implant Not Related to Bone-Ingrowth	238	238
Appropriate Term/Code Not Available	215	215
Degraded	209	209
Packaging Problem	195	195
Patient Device Interaction Problem	171	171
Loss of or Failure to Bond	168	168
Nonstandard Device	153	153
Difficult to Insert	147	147
Tear, Rip or Hole in Device Packaging	143	143
Material Disintegration	140	140
Unstable	116	116
Manufacturing, Packaging or Shipping Problem	100	100
Break	92	92
Patient-Device Incompatibility	73	73
Difficult to Remove	68	68
Detachment of Device or Device Component	67	67
Unintended Movement	66	66
Inadequacy of Device Shape and/or Size	63	63
Device-Device Incompatibility	61	61
Positioning Failure	52	52
Loose or Intermittent Connection	51	51
Separation Failure	40	40
No Apparent Adverse Event	37	37
Off-Label Use	32	32
Failure to Osseointegrate	32	32
Migration or Expulsion of Device	27	27
Material Integrity Problem	22	22
Delivered as Unsterile Product	22	22
Mechanical Problem	20	20
Separation Problem	17	17
Mechanical Jam	15	15
Material Deformation	14	14
Material Twisted/Bent	14	14
Physical Resistance/Sticking	13	13
Positioning Problem	13	13

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Code Available	7830	7832
Pain	7390	7390
Foreign Body Reaction	3075	3075
Test Result	2245	2245
Unspecified Infection	2170	2171
Osteolysis	1524	1524
Joint Dislocation	1514	1514
Metal Related Pathology	1477	1477
Inadequate Osseointegration	1308	1308
Tissue Damage	1286	1286
Hypersensitivity/Allergic reaction	1221	1221
Discomfort	1168	1168
Injury	847	847
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	839	839
Bone Fracture(s)	748	748
No Information	740	740
Limited Mobility Of The Implanted Joint	729	729
Loss of Range of Motion	637	637
No Clinical Signs, Symptoms or Conditions	633	633
Inflammation	613	613
Insufficient Information	595	595
Necrosis	529	529
Swelling/ Edema	495	495
Ambulation Difficulties	495	495
Failure of Implant	487	487
Reaction	470	470
Distress	469	469
Edema	465	465
Unspecified Tissue Injury	429	429
Adhesion(s)	381	381
No Patient Involvement	375	375
No Known Impact Or Consequence To Patient	335	335
Synovitis	289	289
Joint Laxity	286	286
Scar Tissue	276	276
Deformity/ Disfigurement	268	268
Cyst(s)	239	239
Anxiety	226	226
No Consequences Or Impact To Patient	226	226
Fatigue	225	225
Swelling	208	208
Fall	204	204
Weakness	201	201
Not Applicable	186	186
Local Reaction	185	185
Host-Tissue Reaction	177	177
Ossification	164	164
Hematoma	151	151
Thrombosis	143	143
Muscular Rigidity	132	132

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