MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-05-29 for 22.2MM DIA COCR MOD HEAD -5 NK N/A 163652 manufactured by Biomet Orthopedics.
[18364246]
Legal counsel for patient reported patient underwent total hip arthroplasty on an unknown date and underwent a revision procedure on an unknown date due to patient allegations of pain, lack of mobility, metallosis, inflammation and damage to surrounding bone and tissue. A review of invoice history indicates procedures on (b)(6) 2000, (b)(6) 2002, (b)(6) 2004 and (b)(6) 2009. This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.
Patient Sequence No: 1, Text Type: D, B5
[18533634]
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 6 states,? Material sensitivity reactions.? Number 11 states,? Inadequate range of motion due to improper selection or positioning of components.? Number 19 states,? Postoperative bone fracture and pain.? This report is number 1 of 3 mdrs filed for the same event (reference 1825034-2014-04996 / 04998).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2014-04996 |
| MDR Report Key | 3839593 |
| Report Source | 00 |
| Date Received | 2014-05-29 |
| Date of Report | 2014-05-02 |
| Date of Event | 2002-06-11 |
| Date Mfgr Received | 2014-05-02 |
| Device Manufacturer Date | 2000-09-07 |
| Date Added to Maude | 2014-05-30 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. AMANDA ZAJICEK |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743726782 |
| 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 HEAD -5 NK |
| Generic Name | PROSTHESIS, HIP |
| Product Code | KMC |
| Date Received | 2014-05-29 |
| Model Number | N/A |
| Catalog Number | 163652 |
| Lot Number | 266290 |
| ID Number | N/A |
| Device Expiration Date | 2010-09-30 |
| 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 | 2014-05-29 |