MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2016-11-02 for CEMENTRALIZER 10.5 137638000 manufactured by Depuy Cmw ? Reg. # 9610921.
[59007889]
This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[59007890]
Patient was revised to address femoral stem loosening. Loosening occurred at the cement to implant interface. Competitor cement was used at primary.
Patient Sequence No: 1, Text Type: D, B5
[63298485]
Examination of the reported devices was not possible as they were not returned. A search of the complaints databases finds no other reports against the product and lot code combinations since their release to distribution. The investigation can draw no conclusion with the information provided. Based on the inability to determine root cause, the need for corrective action has not been indicated. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2016-30673 |
| MDR Report Key | 6074053 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2016-11-02 |
| Date of Report | 2016-10-31 |
| Date of Event | 2016-10-31 |
| Date Mfgr Received | 2016-12-14 |
| Device Manufacturer Date | 2014-11-10 |
| Date Added to Maude | 2016-11-02 |
| 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 | CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY CMW |
| Manufacturer Street | CORNFORD RD |
| Manufacturer City | BLACKPOOL FY4 4QQ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | FY4 4QQ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CEMENTRALIZER 10.5 |
| Generic Name | HIP OTHER IMPLANT |
| Product Code | LTO |
| Date Received | 2016-11-02 |
| Catalog Number | 137638000 |
| Lot Number | 594227 |
| 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 CMW ? REG. # 9610921 |
| Manufacturer Address | CORNFORD RD BLACKPOOL FY4 4QQ UK FY4 4QQ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-11-02 |