MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-19 for PROSTHESIS - UNIVERSAL TITANIUM PROSTHESIS 1150000 manufactured by Medtronic Xomed Inc..
[39085787]
Concomitant medical products: 1150000? Prosthesis, universal titanium ro; lot? 0205455836; manufacture date? October 4, 2011; use before date? October 2, 2019; 510k - k002897 1150050? Prosthesis, universal titanium vi; lot? 0205577879; manufacture date? November 29, 2011; use before date? November 27, 2019; 510k? K002897 1150050? Prosthesis, universal titanium vi; lot? 0206234969; manufacture date? October 9, 2012; use before date? October 7, 2020; 510k - k002897. (b)(4). 1150000, lot number 0205455047: one un-sealed sample was received. There was evidence of biological contaminants based off of the reactivity with hydrogen peroxide. When compared to the assembly drawing, there was no damage to the packaging to indicate a cause for the complaint and the device is shipped in a rigid capsule. The flex h/a was not returned. The titanium bell legs and head/shaft assembly showed signs of deformation. There were no signs that the device was closed in the lid of the capsule. The bell showed signs of a residue consistent with adhesive in the area that attaches the flex h/a which likely indicates the device was manufactured per the drawing. The contaminants combined with the observed damage likely indicate the issue occurred while handling. 1150000, lot number 0205455836: one un-sealed sample was received. There was evidence of biological contaminants based off of the r eactivity with hydrogen peroxide. When compared to the assembly drawing, only the flex h/a was returned which would have resulted in the reported event. When viewed under magnification, there was evidence the flex h/a was attached at some point to the bell based off of the mounting area. There was no damage to the packaging to indicate a cause for the complaint and the device is shipped in a rigid capsule. The contaminants combined with the observed damage likely indicate the issue occurred while handling. 1150050, lot number 0205577879: one un-sealed sample was received. There was evidence of biological contaminants based off of the r eactivity with hydrogen peroxide. When compared to the assembly drawing and viewed under magnification, there was a residue consistent with adhesive present where the flex h/a mounts to the bell, which is consistent with proper manufacturing. The flex h/a was sepa rated from the titanium bell at the adhesive joint and was not returned. The head/shaft assembly measured less than 0. 23? [required is 0. 400+-. 012] and the shaft was consistent with being trimmed. The contaminants combined with the observed damage likely indicate the issue occurred while handling. 1150050, lot number 0206234969: one un-sealed sample was received. There was evidence of biological contaminants based off of the r eactivity with hydrogen peroxide. When compared to the assembly drawing and viewed under magnification, there was a residue consistent with adhesive present where the flex h/a mounts to the bell, which is consistent with proper manufacturing. The bell legs were de formed. The flex h/a was separated from the titanium bell at the adhesive joint. The head/shaft assembly measured less than 0. 19? [required is 0. 400+-. 012] and the shaft was consistent with being trimmed. The contaminants combined with the observed damage likely i ndicate the issue occurred while handling. H10. Blank fields on this report are the result of information not being provided by initial reporter. This device is used for therapeutic purposes.
Patient Sequence No: 1, Text Type: N, H10
[39085788]
Intraoperative, the shoe of four prosthesis devices dropped (detached). There was no injury reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2016-00047 |
| MDR Report Key | 5447998 |
| Date Received | 2016-02-19 |
| Date of Report | 2016-01-27 |
| Date of Event | 2016-01-27 |
| Date Mfgr Received | 2016-01-27 |
| Device Manufacturer Date | 2011-10-04 |
| Date Added to Maude | 2016-02-19 |
| 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 | URIZA SHUMS |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328405 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROSTHESIS - UNIVERSAL TITANIUM PROSTHESIS |
| Generic Name | REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL |
| Product Code | ETA |
| Date Received | 2016-02-19 |
| Returned To Mfg | 2016-02-04 |
| Model Number | 1150000 |
| Catalog Number | 1150000 |
| Lot Number | 0205455047 |
| Device Expiration Date | 2019-10-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-19 |