MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08,distributor,health prof report with the FDA on 2015-02-26 for PINN CAN BONE SCREW 6.5MMX20MM 121720500 manufactured by 1219655 Depuy-raynham, A Div. Of Depuy Orthopaedic.
[18928102]
Patient was revised to address a vertically placed cup, cup loosening and squeaking in the hip. The liner was noted to have been fractured and scratches found on it once removed. It was also noted that the patient had fallen several times since implantation.
Patient Sequence No: 1, Text Type: D, B5
[19068166]
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
[23431504]
This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.
Patient Sequence No: 1, Text Type: N, H10
[25012733]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[27567432]
Examination of the reported devices was not possible as they were not returned. A search of the complaints databases identified no other reports against the provided product/lot code combinations. Review of the fractured liner device history records finds no related manufacturing deviations or anomalies that would have contributed to the reported event. Medical records and x-rays were reviewed. The investigation can draw no conclusion with the information provided. Product problem has not been identified. Based on the inability to determine root cause, the need for corrective action has not been indicated. Depuy considers the investigation closed at this time. 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 | 1818910-2015-14684 |
| MDR Report Key | 4548360 |
| Report Source | 05,08,DISTRIBUTOR,HEALTH PROF |
| Date Received | 2015-02-26 |
| Date of Report | 2015-02-02 |
| Date of Event | 2015-02-02 |
| Date Mfgr Received | 2015-09-11 |
| Device Manufacturer Date | 2010-02-03 |
| Date Added to Maude | 2015-02-26 |
| 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 | STEVE DOWELL |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743714918 |
| 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 6.5MMX20MM |
| Generic Name | HIP OTHER IMPLANT |
| Product Code | NDJ |
| Date Received | 2015-02-26 |
| Catalog Number | 121720500 |
| Lot Number | 420720 |
| 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 | 2015-02-26 |