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 2016-12-15 for CEMENTRALIZER 12.0 137621000 manufactured by Depuy Orthopaedics Inc Us.
[62483896]
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. Udi: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[62483897]
Patient was revised to address an acetabular bone fracture and cup loosening. The stem was also noted to be loose. Loosening occurred at the cement to femoral stem interface. Cement manufacturer is unknown.
Patient Sequence No: 1, Text Type: D, B5
[66151077]
No device associated with this report was received for examination. A worldwide complaint database search found no other related incident(s) against the provided product/lot combination(s) since release for distribution. Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Corrective action was not indicated. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 1818910-2016-33500 |
MDR Report Key | 6178242 |
Report Source | DISTRIBUTOR,HEALTH PROFESSION |
Date Received | 2016-12-15 |
Date of Report | 2016-12-07 |
Date of Event | 2016-12-07 |
Date Mfgr Received | 2018-06-26 |
Device Manufacturer Date | 2016-08-29 |
Date Added to Maude | 2016-12-15 |
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 | MR. CHAD GIBSON |
Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
Manufacturer City | WARSAW IN 465810988 |
Manufacturer Country | US |
Manufacturer Postal | 465810988 |
Manufacturer Phone | 5743725905 |
Manufacturer G1 | JTE WARSAW MFG SITE |
Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
Manufacturer City | WARSAW IN 46582 |
Manufacturer Country | US |
Manufacturer Postal Code | 46582 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | CEMENTRALIZER 12.0 |
Generic Name | HIP OTHER IMPLANT |
Product Code | LTO |
Date Received | 2016-12-15 |
Catalog Number | 137621000 |
Lot Number | C74201 |
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 US |
Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2016-12-15 |