MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-08-18 for 22.2MM DIA COCR MOD HD STD NK N/A 163651 manufactured by Biomet Orthopedics.
[4714130]
It was reported that a patient underwent a total hip arthroplasty on an unknown date. Subsequently, a revision procedure has been indicated due to implant wear and/or fracture; however, no revision procedure has been reported to date. Additional information received noted that the patient underwent a hip revision on (b)(6) 2014 due to wear. The modular head was removed and replaced.
Patient Sequence No: 1, Text Type: D, B5
[12174861]
The follow-up report is being filed to relay additional information that 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: "wear and/or deformation of articulating surfaces. "
Patient Sequence No: 1, Text Type: N, H10
[15815439]
It was reported that a patient underwent a total hip arthroplasty on an unknown date. Subsequently, a revision procedure has been indicated due to implant wear and/or fracture; however, no revision procedure has been reported to date.
Patient Sequence No: 1, Text Type: D, B5
[16211523]
The product identification necessary to review manufacturing history was not provided. Current information is insufficient to permit a conclusion as to the cause of the event. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[27649386]
This follow-up report is being filed to correct information that was reported in error on a previous medwatch.
Patient Sequence No: 1, Text Type: N, H10
[29812950]
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. 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: "wear and/or deformation of articulating surfaces. " this report is number 1 of 2 mdr's filed for the same patient (reference 1825034-2014-07135 & 1825034-2015- 00921).
Patient Sequence No: 1, Text Type: N, H10
[29812951]
It was reported that a patient underwent a total hip arthroplasty on an unknown date. Subsequently, the patient underwent a hip revision on (b)(6) 2014 due to wear. The modular head was removed and replaced. Additional information received indicates the patient underwent another revision procedure on (b)(6) 2015 due to dislocation. The acetabular cup, liner and head were removed and replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2014-07135 |
| MDR Report Key | 4017297 |
| Report Source | 07 |
| Date Received | 2014-08-18 |
| Date of Report | 2015-03-10 |
| Date of Event | 2015-02-05 |
| Date Mfgr Received | 2015-03-10 |
| Device Manufacturer Date | 2013-07-02 |
| Date Added to Maude | 2014-08-18 |
| 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 | 0 |
| Event Location | 0 |
| 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 | 2014-08-18 |
| Model Number | N/A |
| Catalog Number | 163651 |
| Lot Number | 540640 |
| ID Number | N/A |
| 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 | 2014-08-18 |