MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2014-01-31 for CERAMIN ON CERAMIC HEDROCEL ONE PIECE PRIMA 02-272-28581 manufactured by Zimmer Trabecular Metal Technology (tmt).
[16912103]
It was reported that a patient, who was part of a clinical trial ((b)(6)), was revised due a disassociation of the ceramic liner. Normally, the adverse event is reported through the annual report from the study; however, as of this date, the study is officially closed. The study number is (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[16945428]
A review of the implant's manufacturing record indicates that it was manufactured to specification. Based on the information available, the root cause of the event cannot be determined. Should add'l info be obtained to further this investigation, this report shall be updated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005751028-2014-00013 |
| MDR Report Key | 3621491 |
| Report Source | 05,08 |
| Date Received | 2014-01-31 |
| Date of Report | 2014-01-31 |
| Date Mfgr Received | 2014-01-08 |
| Device Manufacturer Date | 2009-08-01 |
| Date Added to Maude | 2014-02-12 |
| 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 | BILL HARA |
| Manufacturer Street | 10 POMEROY RD. |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9735760032 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CERAMIN ON CERAMIC HEDROCEL ONE PIECE PRIMA |
| Generic Name | HEDROCEL ACETABULAR CUP WITH CERAMIC |
| Product Code | LPF |
| Date Received | 2014-01-31 |
| Catalog Number | 02-272-28581 |
| Lot Number | 99271471-2 |
| Device Expiration Date | 2004-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER TRABECULAR METAL TECHNOLOGY (TMT) |
| Manufacturer Address | 10 POMEROY RD. PARSIPPANY NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-01-31 |