MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2015-12-02 for PINN CAN BONE SCREW 6.5MMX45MM 121745500 manufactured by 1219655 Depuy-raynham, A Div. Of Depuy Orthopaedic.
[32459322]
This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[32459323]
The patient's medical records indicate the patient was revised to address an intrapelvic protrusion and periprosthetic fracture. Upon revision the patient's acetabular component was found to be completely loose. At this time the patient's cup and screws are being reported.
Patient Sequence No: 1, Text Type: D, B5
[36823036]
No device associated with this report was received for examination. A worldwide complaint database search found no other reported incidents against the provided product/lot combination since release for distribution. Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Corrective action was not indicated. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2015-36146 |
| MDR Report Key | 5260130 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2015-12-02 |
| Date of Report | 2015-11-04 |
| Date of Event | 2015-07-02 |
| Date Mfgr Received | 2016-01-25 |
| Device Manufacturer Date | 2012-09-13 |
| Date Added to Maude | 2015-12-02 |
| 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 | CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PINN CAN BONE SCREW 6.5MMX45MM |
| Generic Name | HIP OTHER IMPLANT |
| Product Code | NDJ |
| Date Received | 2015-12-02 |
| Catalog Number | 121745500 |
| Lot Number | 588328 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-12-02 |