Brand Name | R3 3 HOLE ACET SHELL 52MM |
Type of Device | PRSTHSIS, HIP, SMI-CNSTRIND, UNCMNTD, MTL/PLMER, PR |
Manufacturer (Section D) |
SMITH AND NEPHEW, INC. |
1450 brooks road |
spa park |
memphis TN 38116 |
|
Manufacturer (Section G) |
SMITH & NEPHEW ORTHOPAEDICS LTD |
aurora house |
spa park |
leamington spa CV31 3HL |
UK
CV31 3HL
|
|
Manufacturer Contact |
holly
topping
|
1450 brooks road |
38116 |
memphis, TN
|
5123913905
|
|
MDR Report Key | 8996105 |
MDR Text Key | 157727976 |
Report Number | 3005975929-2019-00327 |
Device Sequence Number | 1 |
Product Code |
MBL
|
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 |
Reporter Occupation |
|
Type of Report
| Initial,Followup |
Report Date |
10/23/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/11/2019 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
|
Device Expiration Date | 03/11/2022 |
Device Catalogue Number | 71335552 |
Device Lot Number | 12CM08257 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 09/24/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Treatment Data |
Date Received: 09/11/2019 Patient Sequence Number: 1 |
|
|