MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,health professional report with the FDA on 2013-06-14 for OSTEONICS SIZED CEMENT-PLUG B003-0140 manufactured by Stryker Orthopaedics-mahwah.
[3544370]
During surgery, when the package was opened, it was found that the cement plug had come off from the plastic plate. The device was implanted.
Patient Sequence No: 1, Text Type: D, B5
[10787153]
An evaluation of the device cannot be performed as the device remained implanted in the patient and was not returned to the manufacturer. Should additional information become available, the evaluation summary will be submitted in a supplemental report. H3 other text : not returned to the manufacturer
Patient Sequence No: 1, Text Type: N, H10
[36361617]
An event regarding an unclear issue involving a cement plug was reported. The event was not confirmed. Method and results: device evaluation and results: visual, dimensional and functional analysis could not be performed as the device was not returned. Medical records received and evaluation: not performed as there is no indication patient factors contributed to the reported event. Device history review: there were no reported discrepancies. Complaint history review: there have been no other events for the referenced lot. Conclusions: 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 (b)(4). If devices and / or additional information become available, this investigation will be reopened.
Patient Sequence No: 1, Text Type: N, H10
[36361618]
During surgery, when the package was opened, it was found that the cement plug had come off from the plastic plate. The device was implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2013-01909 |
| MDR Report Key | 3169203 |
| Report Source | 05,HEALTH PROFESSIONAL |
| Date Received | 2013-06-14 |
| Date of Report | 2013-05-20 |
| Date of Event | 2013-05-18 |
| Date Mfgr Received | 2015-12-22 |
| Device Manufacturer Date | 2012-08-31 |
| Date Added to Maude | 2013-09-10 |
| 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. KEYLA NAVEDO |
| 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 | OSTEONICS SIZED CEMENT-PLUG |
| Generic Name | HIP JOINT METAL/METAL SEMI-CONSTRAINED, WITH A CEMENTED ACETABULAR COMPONENT, PR |
| Product Code | LTO |
| Date Received | 2013-06-14 |
| Catalog Number | B003-0140 |
| Lot Number | 6M8374 |
| Device Expiration Date | 2017-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOPAEDICS-MAHWAH |
| Manufacturer Address | 325 CORPORATE DRIVE MAHWAH NJ 07430 US 07430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-06-14 |