Brand Name | REDAPT MODULAR SHELL 60MM |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
1450 brooks rd. |
memphis TN 38116 |
|
Manufacturer (Section G) |
SMITH & NEPHEW, INC. |
1450 brooks rd. |
|
memphis TN 38116 |
|
Manufacturer Contact |
holly
topping
|
7000 west william cannon drive |
austin, TX 78735
|
5123913905
|
|
MDR Report Key | 16583163 |
MDR Text Key | 311679672 |
Report Number | 1020279-2023-00602 |
Device Sequence Number | 1 |
Product Code |
MBL
|
UDI-Device Identifier | 00885556657867 |
UDI-Public | 00885556657867 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K182109 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Study,User Facility,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
04/21/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 71352360 |
Device Catalogue Number | 71352360 |
Device Lot Number | 20HM09832 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/16/2023
|
Initial Date FDA Received | 03/21/2023 |
Supplement Dates Manufacturer Received | 04/20/2023
|
Supplement Dates FDA Received | 04/21/2023
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/13/2020 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | R3 ACET LNR 40X60MM(PN:71338681,LN:19MM04455).; RDPT LCKNG SCRW25MM(PN:71354504,LN:20CM05181).; RDPT LCKNG SCRW35MM(PN:71354506,LN:18LM00334).; RFLCTN SPH HD SCRW25MM(PN:71332525,LN:20LB00631).; RFLCTN SPH HD SCRW35MM(PN:71332535,LN:20MM01549). |
Patient Outcome(s) |
Required Intervention;
Hospitalization;
|
Patient Age | 36 YR |
Patient Sex | Male |
|
|