MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07,company representative, report with the FDA on 2015-05-26 for EPSILON ACETABULAR DURASUL STANDARD INSERT 437632053 manufactured by Zimmer Inc..
[19407725]
It is reported the pt was revised due to dislocation.
Patient Sequence No: 1, Text Type: D, B5
[19769941]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[57414214]
No devices or photos were received; therefore the condition of the components is unknown. Device history records for lot code associated with the liner were reviewed. No deviations or anomalies were noted. The reported (b)(4) design controlled device is used for treatment. Review of the compatibility confirmed that these are an approved compatible combination. Review of the complaint history for lot code associated with the liner indicated no prior complaints for this lot. Surgical notes were not provided. It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique. Relevant medical history and adherence to rehabilitation protocol are unknown. A definitive root cause cannot be determined with the information provided.
Patient Sequence No: 1, Text Type: N, H10
[57414215]
It was further reported that the patient's hip was revised to a constrained liner due to potential for dislocation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1822565-2015-00761 |
| MDR Report Key | 4797713 |
| Report Source | 04,07,COMPANY REPRESENTATIVE, |
| Date Received | 2015-05-26 |
| Date of Report | 2015-04-21 |
| Date of Event | 2012-08-13 |
| Date Mfgr Received | 2015-04-21 |
| Device Manufacturer Date | 2009-12-01 |
| Date Added to Maude | 2015-05-28 |
| 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 | KEVIN ESCAPULE |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 8006136131 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EPSILON ACETABULAR DURASUL STANDARD INSERT |
| Generic Name | HIP PROSTHESIS |
| Product Code | KWB |
| Date Received | 2015-05-26 |
| Catalog Number | 437632053 |
| Lot Number | 61317689 |
| Device Expiration Date | 2014-11-30 |
| 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 INC. |
| Manufacturer Address | P.O. BOX 708 WARSAW IN 465810708 US 465810708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-05-26 |