Brand Name | REF SPHER HEAD SCREW 30MM |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CA-P |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
1450 brooks road |
memphis TN 38116 |
|
Manufacturer (Section G) |
SMITH & NEPHEW, INC. |
1450 brooks road |
|
memphis TN 38116 |
|
Manufacturer Contact |
markus
poettker
|
schachenallee 29 |
aarau 5001
|
SZ
5001
|
|
MDR Report Key | 6471715 |
MDR Text Key | 72094795 |
Report Number | 1020279-2017-00245 |
Device Sequence Number | 1 |
Product Code |
MEH
|
UDI-Device Identifier | 03596010460479 |
UDI-Public | 03596010460479 |
Combination Product (y/n) | N |
Reporter Country Code | SF |
PMA/PMN Number | K990666 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
08/31/2017 |
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 Catalogue Number | 71332530 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/18/2017 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/22/2017 |
Initial Date FDA Received | 04/07/2017 |
Supplement Dates Manufacturer Received | 03/22/2017
|
Supplement Dates FDA Received | 08/31/2017
|
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 Sequence Number | 1 |
Treatment | R3 20DEG XLPEACET LNR 36MMX60MM, (B)(4)/14GM19376; R3 MULTIHOLE ACETAB SHELL60MM,(B)(4)/14DM02893; REF SPHER HEAD SCREW 15MM, (B)(4)/13MM11402; REF SPHER HEAD SCREW 20MM, (B)(4)/15CM17075; REF SPHER HEAD SCREW 20MM, (B)(4)/15CM17075; REF THREADED HOLE COVER, (B)(4)/15EM05045; UNKNOWN REF SPHER HEAD SCREW |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 73 YR |
|
|