Brand Name | GLOBAL AP HUMERAL HD 44X21 ECC |
Type of Device | GLOBAL AP IMPLANTS : SHOULDER HUMERAL HEADS |
Manufacturer (Section D) |
DEPUY ORTHOPAEDICS INC US |
700 orthopaedic drive |
warsaw IN 46581 0988 |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic dr. |
|
warsaw IN 46581 0988 |
|
Manufacturer Contact |
kara
ditty-bovard
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
6107428552
|
|
MDR Report Key | 13636213 |
MDR Text Key | 286360481 |
Report Number | 1818910-2022-03866 |
Device Sequence Number | 1 |
Product Code |
KWS
|
UDI-Device Identifier | 10603295005896 |
UDI-Public | 10603295005896 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
03/01/2022 |
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? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 1130-44-620 |
Device Catalogue Number | 113044620 |
Device Lot Number | B1RFA1000 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/15/2022
|
Initial Date FDA Received | 03/01/2022 |
Supplement Dates Manufacturer Received | 03/25/2022
|
Supplement Dates FDA Received | 03/29/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/12/2007 |
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 | COMPETITOR CEMENT; CROSSLINK ANCHOR PG GLENOID 44; GLOBAL AP HUMERAL HD 44X21 ECC; GLOBAL AP PC STEM 14 MM |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 75 YR |
Patient Sex | Female |
Patient Weight | 101 KG |