MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2011-09-08 for CEMENTRALIZER 11.0 137620000 manufactured by Depuy Warsaw.
[19868257]
Patient was revised to address infection. Loosening of the stem was also reported at the cement/implant interface. The manufacturer of the cement used in the primary surgery is unknown.
Patient Sequence No: 1, Text Type: D, B5
[19944931]
This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.
Patient Sequence No: 1, Text Type: N, H10
[22134729]
The devices associated with this report were not returned. Review of the sterilization certifications for the provided product/lot combinations did not reveal any related deviations or anomalies. Per the sterilization certificates, validated parameters were met. No error in sterile processing was identified. Based on the investigation, the need for corrective action was not indicated. Depuy considers the investigation closed at this time. Should the product or additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2011-17556 |
| MDR Report Key | 2237955 |
| Report Source | 05,08 |
| Date Received | 2011-09-08 |
| Date of Report | 2011-08-15 |
| Date of Event | 2011-08-15 |
| Date Mfgr Received | 2011-08-15 |
| Device Manufacturer Date | 2008-12-01 |
| Date Added to Maude | 2011-09-08 |
| 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 | KATHERINE SEPPA |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer G1 | DEPUY WARSAW |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CEMENTRALIZER 11.0 |
| Generic Name | FEMORAL STEM ACCESSORY |
| Product Code | LTO |
| Date Received | 2011-09-08 |
| Catalog Number | 137620000 |
| Lot Number | C5PLL1000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY WARSAW |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-09-08 |