Brand Name | SIZE 8 ACCOLADE II BROACH |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
Manufacturer (Section D) |
STRYKER ORTHOPAEDICS-MAHWAH |
325 corporate drive |
mahwah NJ 07430 |
|
MDR Report Key | 7569346 |
MDR Text Key | 110078487 |
Report Number | 0002249697-2018-01701 |
Device Sequence Number | 1 |
Product Code |
LPH
|
UDI-Device Identifier | 07613327252637 |
UDI-Public | 07613327252637 |
Combination Product (y/n) | N |
PMA/PMN Number | K153345 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,other |
Type of Report
| Initial,Followup |
Report Date |
06/29/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 1020-5208 |
Device Lot Number | 136084 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/02/2018 |
Initial Date Manufacturer Received |
05/09/2018 |
Initial Date FDA Received | 06/05/2018 |
Supplement Dates Manufacturer Received | 05/31/2018
|
Supplement Dates FDA Received | 06/29/2018
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|