MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-07-21 for 22.2MM DIA COCR MOD HD STD NK N/A 163651 manufactured by Biomet Orthopedics.
[50175983]
Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly or deviation. There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 8 states, "dislocation and subluxation due to inadequate fixation and improper positioning. Muscle and fibrous tissue laxity can also contribute to these conditions. " this report is based on allegations set forth in plaintiff? S complaint and the allegations contained therein are unverified. This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2016-02715 / 02716). Additional events for this patient reported on medwatch numbers 1825034-2016-02713 / 02714 and 02717 / 02719. Not returned by attorney.
Patient Sequence No: 1, Text Type: N, H10
[50175984]
Legal counsel reports patient underwent a right hip revision procedure approximately one year post-implantation due to alleged dislocation. The femoral head and acetabular liner were removed and replaced. This report is based on allegations set forth in plaintiffcomplaint and the allegations contained therein are unverified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2016-02715 |
| MDR Report Key | 5813954 |
| Report Source | OTHER |
| Date Received | 2016-07-21 |
| Date of Report | 2016-06-24 |
| Date of Event | 2001-04-13 |
| Date Mfgr Received | 2016-06-24 |
| Device Manufacturer Date | 1999-05-10 |
| Date Added to Maude | 2016-07-21 |
| 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 |
| Reporter Occupation | ATTORNEY |
| 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 | 22.2MM DIA COCR MOD HD STD NK |
| Generic Name | PROSTHESIS, HIP |
| Product Code | KMC |
| Date Received | 2016-07-21 |
| Model Number | N/A |
| Catalog Number | 163651 |
| Lot Number | 907560 |
| ID Number | N/A |
| Device Expiration Date | 2009-05-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| 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. Hospitalization; 2. Required No Informationntervention | 2016-07-21 |