MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2007-08-23 for PRSVN MB INSERT SZ4 9.5MM 149815408 manufactured by Depuy Cork, A Division Of Depuy Orthopaedics.
[18238503]
Patient was revised to address tibial loosening and possible poly deformation.
Patient Sequence No: 1, Text Type: D, B5
[18389865]
Examination was not possible as no product was returned. A search of the warsaw and international complaint database did not find any additional reports of this nature for the product code/lots provided since their respective release for distribution. The root cause could not be determined. No evidence was found that would suggest product error was a contributing factor. The initial report states that it is not suspected that the product failed to meet specifications. The need for corrective action was not indicated. Should additional information be received, the complaint will be reopened. Depuy considers the investigation closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2007-02707 |
| MDR Report Key | 903049 |
| Report Source | 05,08 |
| Date Received | 2007-08-23 |
| Date of Report | 2007-08-06 |
| Date of Event | 2007-08-06 |
| Date Mfgr Received | 2007-08-06 |
| Device Manufacturer Date | 2002-07-01 |
| Date Added to Maude | 2007-08-31 |
| 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 | GINNY STAMBERGER, MGR |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 5743727333 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Street | LOUGHBEG RINGASKIDDY CTY. |
| Manufacturer City | CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRSVN MB INSERT SZ4 9.5MM |
| Generic Name | 87MBD |
| Product Code | MBD |
| Date Received | 2007-08-23 |
| Model Number | NA |
| Catalog Number | 149815408 |
| Lot Number | 1037245 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 879736 |
| Manufacturer | DEPUY CORK, A DIVISION OF DEPUY ORTHOPAEDICS |
| Manufacturer Address | LOUGHBEG RINGASKIDDY CTY CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-08-23 |