MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2017-01-25 for BIOMET OFFSET TIBIAL TRAY 63MM N/A 141481 manufactured by Biomet Orthopedics.
[65706287]
Concomitant medical product(s) - vanguard(tm) femoral distal augment 10mm x 60mm ll/rm, catalog# 184202, lot# 769060. Vanguard (tm) femoral distal augment 10mm x 60mm rl/lm, catalog# 184182, lot# 807910. Biomet splined knee stem 14mm x 120 mm, catalog# 141654, lot# 485730. Vanguard (tm) femoral posterior augment 5mm x 60mm ll/rm, catalog# 184162, lot# 741160. Biomet splined knee stem 10mm x 80mm, catalog# 141610, lot# 298100. Biomet offset tibial tray adaptor 5. 0 mm, catalog# 141491, lot# 326010. Vanguard (tm) femoral posterior augment 5mm x 60 mm rl/lm, catalog# 184142, lot# 668770. Biomet series a thin patella 37mm x 8. 6 mm, catalog# 184788, lot# 968230,. Vanguard (tm) dcm tibial bearing 20mm x 63/67 mm small post, catalog# 183830, lot# 073550. Custom titanium vanguard ssk femoral, catalog# cp113123, lot# 474920. Event is being reported to fda on eleven medwatches since the limited information available indicates that a revision procedure occurred. Should additional information be received regarding the revision procedure, the complaint will be reassessed and, if warranted, further medwatch reports will be submitted. This report is number 8 of 11 mdrs filed for the same patient (reference 0001825034 - 2017 - 00253 , 0001825034 - 2017 - 00255 , 0001825034 - 2017 - 00257 , 0001825034 - 2017 - 00258, 0001825034 - 2017 - 00259 , 0001825034 - 2017 - 00261, 0001825034 - 2017 - 00262 , 0001825034 - 2017 - 00265 , 0001825034 - 2017 - 00266 ,0001825034 - 2017 - 00267 ).
Patient Sequence No: 1, Text Type: N, H10
[65706288]
It was reported that the patient was revised due to unknown reasons seven (7) months post implantation.
Patient Sequence No: 1, Text Type: D, B5
[75109470]
Upon receipt of additional information, it was determined that this device should not have been reported as it was not involved in the event. The initial report was submitted in error and should be voided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2017-00264 |
| MDR Report Key | 6276222 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2017-01-25 |
| Date of Report | 2017-05-09 |
| Date of Event | 2011-06-01 |
| Date Mfgr Received | 2017-04-19 |
| Device Manufacturer Date | 2010-07-28 |
| Date Added to Maude | 2017-01-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOMET OFFSET TIBIAL TRAY 63MM |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | MBV |
| Date Received | 2017-01-25 |
| Model Number | N/A |
| Catalog Number | 141481 |
| Lot Number | 894190 |
| ID Number | N/A |
| Device Expiration Date | 2015-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-01-25 |