MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-05-13 for 22.2MM DIA COCR MOD HD STD NK N/A 163651 manufactured by Biomet Orthopedics.
[20973264]
Patient's legal counsel reported patient underwent an initial right hip arthroplasty on (b)(6) 2004. Legal counsel further reports patient allegations of pain, swelling, inflammation, loss of range of motion, damage to surrounding bone/tissue, lack of mobility, elevated metal ion levels, metal poisoning, and metallosis. No revision procedure has been reported to date.
Patient Sequence No: 1, Text Type: D, B5
[21299377]
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 1 states,? Material sensitivity reactions.? Number 6 states,? Inadequate range of motion due to improper selection or positioning of components.? Number 14 states,? Intraoperative or postoperative bone fracture and/or postoperative pain.? Number 15 states,? Elevated metal ion levels have been reported with metal-on-metal articulating surfaces.?
Patient Sequence No: 1, Text Type: N, H10
[32350677]
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, 11. Wear and/or deformation of articulating surfaces. 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 mdr's filed for the same event (reference 1825034-2014-03927 and 05684).
Patient Sequence No: 1, Text Type: N, H10
[32350678]
Patient's legal counsel reported patient underwent an initial right hip arthroplasty on (b)(6) 2004. Legal counsel further reports patient allegations of pain, swelling, inflammation, loss of range of motion, damage to surrounding bone/tissue, lack of mobility, elevated metal ion levels, metal poisoning, and metallosis. Additional information provided in patient medical records indicate that the right revision procedure was performed on (b)(6) 2014 due to polyethylene wear. The patient's operative report noted scar tissue and removal of head, cup and liner. 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
| Report Number | 0001825034-2014-03927 |
| MDR Report Key | 3808735 |
| Report Source | 00 |
| Date Received | 2014-05-13 |
| Date of Report | 2014-06-10 |
| Date of Event | 2014-04-28 |
| Date Mfgr Received | 2014-06-10 |
| Device Manufacturer Date | 2004-05-20 |
| Date Added to Maude | 2014-05-13 |
| 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 HD STD NK |
| Generic Name | PROSTHESIS, HIP |
| Product Code | KMC |
| Date Received | 2014-05-13 |
| Model Number | N/A |
| Catalog Number | 163651 |
| Lot Number | 153180 |
| ID Number | N/A |
| Device Expiration Date | 2014-05-30 |
| 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. Hospitalization; 2. Required No Informationntervention | 2014-05-13 |