MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2014-06-16 for TRIDENT 0? X3 INSERT 32MM ID 623-00-32F manufactured by Stryker Orthopaedics-mahwah.
[4592507]
It was reported that there was a revision of a right total hip due to instability.
Patient Sequence No: 1, Text Type: D, B5
[12047621]
It was noted that the device is not available for evaluation due to hospital policy. Additional information has been requested and if received, will be provided in the supplemental report. Hospital policy.
Patient Sequence No: 1, Text Type: N, H10
[32225092]
Device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies. Complaint history review: there have been no other events reported for the reported manufacturing lot. The event could not be confirmed nor the root cause of the reported event determined due to the minimal information received. No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics. If devices and / or additional information become available, this investigation will be reopened.
Patient Sequence No: 1, Text Type: N, H10
[32225093]
It was reported that there was a revision of a right total hip due to instability.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2014-02288 |
| MDR Report Key | 3875113 |
| Report Source | 00,05 |
| Date Received | 2014-06-16 |
| Date of Report | 2014-05-22 |
| Date of Event | 2014-05-22 |
| Date Mfgr Received | 2015-05-13 |
| Device Manufacturer Date | 2014-01-27 |
| Date Added to Maude | 2014-06-16 |
| 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 | MS. BEVERLY LIMA |
| 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 | TRIDENT 0? X3 INSERT 32MM ID |
| Generic Name | IMPLANT |
| Product Code | LDH |
| Date Received | 2014-06-16 |
| Catalog Number | 623-00-32F |
| Lot Number | MNANT0 |
| ID Number | STERILE LOT MSGNAZ0J5 |
| Device Expiration Date | 2019-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOPAEDICS-MAHWAH |
| Manufacturer Address | 325 CORPORATE DRIVE MAHWAH NJ 07430 US 07430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-06-16 |