Brand Name | RINGLOC HIP SYSTEM ACETABULAR LINER |
Type of Device | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU |
Manufacturer (Section D) |
ZIMMER BIOMET, INC. |
56 e. bell drive |
warsaw IN 46582 |
|
Manufacturer (Section G) |
ZIMMER BIOMET, INC. |
56 e. bell drive |
|
warsaw IN 46582 |
|
Manufacturer Contact |
christina
arnt
|
56 e. bell dr. |
warsaw, IN 46582
|
5745273773
|
|
MDR Report Key | 7590481 |
MDR Text Key | 110704100 |
Report Number | 0001825034-2018-03890 |
Device Sequence Number | 1 |
Product Code |
MAY
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | PK090103 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,health profession |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
06/11/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/12/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Physician
|
Device Expiration Date | 04/06/2022 |
Device Model Number | N/A |
Device Catalogue Number | EP-108223 |
Device Lot Number | 761320 |
Other Device ID Number | (01) 0 0880304 46909 9 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 05/18/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/06/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |
Treatment | (B)(4) CER BIOLOXD OPTION HD 36MM; (B)(4) REGEN/RNGLC+ LTD 52MM SZ 23; (B)(4) TPRLC 133 MP TYPE1 PPS HO 12.0; (B)(4) UNKNOWN LOT TI LOW PROFILE SCREW 6.5X40MM |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 47 YR |