MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2010-05-14 for CEM RESTRICTOR LG 546112000 manufactured by Depuy Orthopaedics, Inc..
[1492735]
Pt had staph infection 2-3 months post-op which did not respond to conservative treatment. Therefore, the pt was revised and a cement spacer implanted.
Patient Sequence No: 1, Text Type: D, B5
[8650461]
No product was returned. A search of the complaint database did not show any other reports against the reported product lot code. The investigation could not draw any conclusions about the reported infection. No evidence was found suggesting product error was a contributing factor and the need for corrective action is not indicated. Depuy considers the investigation closed at this time. Should additional info be received, the investigation will be re-opened.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2010-02862 |
| MDR Report Key | 1692248 |
| Report Source | 05,08 |
| Date Received | 2010-05-14 |
| Date of Report | 2010-04-14 |
| Date of Event | 2010-04-14 |
| Date Mfgr Received | 2010-04-14 |
| Device Manufacturer Date | 2009-07-01 |
| Date Added to Maude | 2010-05-20 |
| 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, 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 | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 46581098 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 0988 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CEM RESTRICTOR LG |
| Generic Name | 87JDS |
| Product Code | JDK |
| Date Received | 2010-05-14 |
| Model Number | NA |
| Catalog Number | 546112000 |
| Lot Number | DX9KT1000 |
| ID Number | NA |
| 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 ORTHOPAEDICS, INC. |
| Manufacturer Address | 700 ORTHOPAEDIC DR. WARSAW IN 46581098 US 46581 0988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-05-14 |