MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2015-11-05 for TRITANIUM PRIMARY ACETABULAR SHELL UNK_REC manufactured by Stryker Orthopaedics-mahwah.
[30465037]
An evaluation of the device cannot be performed as the device was not returned to the manufacturer. Additional information was requested and if it becomes available will be submitted in a supplemental report. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[30465038]
Presentation given by dr. (b)(6). From (b)(4) at the ista (international society for technology in arthroplasty), alleged "multiple radiolucencies and inferior clinical scores at mid-term follow up" for tritanium primary acetabular components.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2015-03558 |
| MDR Report Key | 5203937 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2015-11-05 |
| Date of Report | 2015-10-05 |
| Date of Event | 2015-09-30 |
| Date Mfgr Received | 2015-10-05 |
| Date Added to Maude | 2015-11-05 |
| 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 | MS. RITA INTORRELLA |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS-MAHWAH |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRITANIUM PRIMARY ACETABULAR SHELL |
| Generic Name | HIP IMPLANT |
| Product Code | KWB |
| Date Received | 2015-11-05 |
| Catalog Number | UNK_REC |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOPAEDICS-MAHWAH |
| Manufacturer Address | 325 CORPORATE DRIVE MAHWAH NJ 07430 US 07430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-11-05 |