MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2008-07-09 for LCS COMPLETE M/B PAT CEM STD+ 149825002 manufactured by Depuy Orthopaedics, Inc..
[15506440]
Pt was revised to address tibial collapse (right side). It was noted that the pt had soft bone.
Patient Sequence No: 1, Text Type: D, B5
[15727813]
Examination was not possible as no product was returned. The investigation was limited to the info provided, as the lot number required to review the device history records and complaint history was not provided. Although the investigation could not determine the exact root cause, the pt's bone quality may have been a contributing factor. The initial report states that it is not suspected that the product failed to meet specs or contributed to the reported event. The need for corrective action is not indicated. Depuy considers the investigation closed at this time. Should the product and/or add'l info 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 | 1818910-2008-02581 |
| MDR Report Key | 1074138 |
| Report Source | 05,08 |
| Date Received | 2008-07-09 |
| Date of Report | 2008-06-11 |
| Date of Event | 2008-06-11 |
| Date Mfgr Received | 2008-06-11 |
| Date Added to Maude | 2008-07-16 |
| 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 | 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 | LCS COMPLETE M/B PAT CEM STD+ |
| Generic Name | 87MBD |
| Product Code | MBD |
| Date Received | 2008-07-09 |
| Model Number | NA |
| Catalog Number | 149825002 |
| Lot Number | UNK |
| 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 | 1041964 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Address | 700 ORTHOPAEDIC DR. WARSAW IN 465810988 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-07-09 |