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	866	869

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	8308	8308
Device Dislodged or Dislocated	1925	1925
Naturally Worn	1904	1904
Loss of Osseointegration	1035	1035
Insufficient Information	1034	1034
Fracture	626	626
Osseointegration Problem	623	623
Material Erosion	543	543
Device Contaminated During Manufacture or Shipping	520	520
Migration	477	480
Corroded	419	419
Use of Device Problem	363	363
Biocompatibility	326	326
Noise, Audible	315	315
Malposition of Device	292	292
Loosening of Implant Not Related to Bone-Ingrowth	235	235
Appropriate Term/Code Not Available	215	215
Degraded	209	209
Packaging Problem	188	188
Patient Device Interaction Problem	171	171
Loss of or Failure to Bond	168	168
Nonstandard Device	153	153
Difficult to Insert	145	145
Material Disintegration	140	140
Tear, Rip or Hole in Device Packaging	140	140
Unstable	116	116
Manufacturing, Packaging or Shipping Problem	100	100
Break	92	92
Patient-Device Incompatibility	73	73
Detachment of Device or Device Component	67	67
Difficult to Remove	67	67
Unintended Movement	66	66
Inadequacy of Device Shape and/or Size	63	63
Device-Device Incompatibility	61	61
Loose or Intermittent Connection	51	51
Positioning Failure	50	50
Separation Failure	40	40
No Apparent Adverse Event	36	36
Failure to Osseointegrate	32	32
Off-Label Use	31	31
Migration or Expulsion of Device	27	27
Delivered as Unsterile Product	22	22
Material Integrity Problem	22	22
Mechanical Problem	20	20
Separation Problem	17	17
Mechanical Jam	15	15
Material Twisted/Bent	14	14
Positioning Problem	13	13
Material Deformation	13	13
Physical Resistance/Sticking	13	13

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Code Available	7830	7832
Pain	7368	7368
Foreign Body Reaction	3061	3061
Test Result	2245	2245
Unspecified Infection	2157	2158
Osteolysis	1521	1521
Joint Dislocation	1510	1510
Metal Related Pathology	1459	1459
Inadequate Osseointegration	1306	1306
Tissue Damage	1286	1286
Hypersensitivity/Allergic reaction	1220	1220
Discomfort	1168	1168
Injury	847	847
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	837	837
Bone Fracture(s)	742	742
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	619	619
Inflammation	612	612
Insufficient Information	584	584
Necrosis	529	529
Swelling/ Edema	495	495
Ambulation Difficulties	495	495
Failure of Implant	478	478
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	288	288
Joint Laxity	282	282
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	202	202
Weakness	201	201
Not Applicable	186	186
Local Reaction	185	185
Host-Tissue Reaction	177	177
Ossification	162	162
Hematoma	151	151
Thrombosis	143	143
Muscular Rigidity	130	130

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