MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-08 for G7 NEUTRAL E1 LINER 32MM F N/A 010000850 manufactured by Biomet Orthopedics.
[27911264]
Current information is insufficient to permit a conclusion as to the cause of the event. Date of birth - 1946, expiration date - unknown, manufacture date? Unknown. There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states,? Material sensitivity reactions.? Number 2 states, "early or late postoperative infection and/or allergic reaction. " this report is number 3 of 4 mdrs filed for the same event (reference 1825034-2015-04169 / 04171 & 04235).
Patient Sequence No: 1, Text Type: N, H10
[27911285]
It was reported that patient underwent right total hip arthroplasty on (b)(6) 2015. Subsequently, patient was admitted to hospital on (b)(6) 2015 to be treated with medication due to an infection with moderate traces of staph. Aureus. No revision has yet been reported.
Patient Sequence No: 1, Text Type: D, B5
[30211608]
This follow-up report is being filed to correct and relay additional information, which was unknown at the time of the initial medwatch.
Patient Sequence No: 1, Text Type: N, H10
[38254119]
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. Remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[43633796]
Upon reassessment of the reported event, it was determined to be not reportable. The initial report was forwarded in error and should be voided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2015-04171 |
| MDR Report Key | 5138146 |
| Date Received | 2015-10-08 |
| Date of Report | 2016-03-30 |
| Date of Event | 2015-09-08 |
| Date Mfgr Received | 2016-03-30 |
| Device Manufacturer Date | 2014-12-08 |
| Date Added to Maude | 2015-10-08 |
| 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. MEGAN HAAS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743726700 |
| 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 | G7 NEUTRAL E1 LINER 32MM F |
| Generic Name | PROSTHESIS, HIP |
| Product Code | LKD |
| Date Received | 2015-10-08 |
| Model Number | N/A |
| Catalog Number | 010000850 |
| Lot Number | 3471472 |
| ID Number | N/A |
| Device Expiration Date | 2019-12-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2015-10-08 |