Brand Name | SL-PLUS STEM LATERAL 4 NON-CEMENTED |
Type of Device | PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED |
Manufacturer (Section D) |
SMITH & NEPHEW ORTHOPAEDICS AG |
schachenallee 29 |
aarau CH-50 00 |
SZ CH-5000 |
|
Manufacturer (Section G) |
SMITH & NEPHEW ORTHOPAEDICS AG |
schachenallee 29 |
|
aarau CH-50 00 |
SZ
CH-5000
|
|
Manufacturer Contact |
holly
topping
|
7000 west william cannon drive |
austin, TX 78735
|
5123913905
|
|
MDR Report Key | 15089666 |
MDR Text Key | 296466892 |
Report Number | 9613369-2022-00445 |
Device Sequence Number | 1 |
Product Code |
KWY
|
UDI-Device Identifier | 07611996078046 |
UDI-Public | 07611996078046 |
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K072852 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Study,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
08/19/2022 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 75002756 |
Device Catalogue Number | 75002756 |
Device Lot Number | C0803006 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
06/30/2022
|
Initial Date FDA Received | 07/22/2022 |
Supplement Dates Manufacturer Received | 08/03/2022
|
Supplement Dates FDA Received | 08/20/2022
|
Was Device Evaluated by Manufacturer? |
No
|
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 | METAL METAL BALL HEAD 28L CONE 12/14, LOT#:C080059; POLARCUP LINER 59/28, LOT#:J171L43; UNKN. POLARCUP SHELL (UNKN. TYPE) |
Patient Outcome(s) |
Required Intervention;
Hospitalization;
|
Patient Age | 83 YR |
Patient Sex | Male |
|
|