Brand Name | R3 3 HOLE ACET SHELL MM48 |
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 | 16583091 |
MDR Text Key | 311677835 |
Report Number | 1020279-2023-00598 |
Device Sequence Number | 1 |
Product Code |
MBL
|
UDI-Device Identifier | 03596010598226 |
UDI-Public | 03596010598226 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K070756 |
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 |
Report Date |
03/21/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/21/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 71335548 |
Device Catalogue Number | 71335548 |
Device Lot Number | 21GW06383 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/16/2023 |
Date Device Manufactured | 07/26/2021 |
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 | OX FM HD 12/14TPR 32MM+4(PN:71343204,LN:22AM14383); R3 ACTBLR LNR 32MMX48MM(PN:71339548,LN:20LM01621); RFLCTN HD SCRW 25MM(PN:71332525,LN:22FB00612); RLLY AB BNE CMNT 40G(PN:71271570,LN:22CTC0192) |
Patient Outcome(s) |
Required Intervention;
Hospitalization;
|
Patient Age | 59 YR |
Patient Sex | Female |
|
|