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 2015-03-17 for PINN CAN BONE SCREW 6.5MMX30MM 121730500 manufactured by Depuy Orthopaedics Inc Us.
[5695934]
Patient was revised to address pain and black staining of the tissues.
Patient Sequence No: 1, Text Type: D, B5
[13032333]
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
[25176058]
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
[25176059]
Update rec'd 03/23/2015 - the patient's medical records were received. Medical records were reviewed for mdr reportability. According to the medical records the patient was revised to address increasing pain. Upon revision metallosis, black synovial tissue, and a cyst in the greater trochanter were found. Also noted, one of the screws in the acetabulum was prominent but there was no indication of wear on the backside of the liner, the screw was removed.
Patient Sequence No: 1, Text Type: D, B5
[32000468]
No device associated with this report was received for examination. A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution. A worldwide lot specific complaint database search, or device history record (dhr) review was not possible for the unknown lot code(s). 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 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
[46513557]
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
[46513558]
Update rec? D 05/18/2016 - litigation papers received. In addition to what was previously reported, litigation also alleges the patient suffers from elevated metal ions, metal debris, and limited mobility. There is no new information that would change the existing mdr decision. Updated head/liner/screws and added stem. Complaint updated 06/03/2016.
Patient Sequence No: 1, Text Type: D, B5
[73581554]
Patient Sequence No: 1, Text Type: N, H10
[73581555]
Update 3/31/2017 pfs and medical records received. After review of the medical records for mdr reportability, lab values were provided that confirmed elevated chromium level. The unknown screw is being rejected as only one screw implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2015-16317 |
| MDR Report Key | 4610041 |
| Report Source | 05,08,DISTRIBUTOR,HEALTH PROF |
| Date Received | 2015-03-17 |
| Date of Report | 2015-03-02 |
| Date of Event | 2015-03-02 |
| Date Mfgr Received | 2019-02-14 |
| Device Manufacturer Date | 2004-05-10 |
| Date Added to Maude | 2015-03-17 |
| 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. KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | JTE WARSAW MFG SITE |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PINN CAN BONE SCREW 6.5MMX30MM |
| Generic Name | HIP OTHER IMPLANT |
| Product Code | NDJ |
| Date Received | 2015-03-17 |
| Catalog Number | 121730500 |
| Lot Number | YS5JG1000 |
| Device Expiration Date | 2009-05-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS INC US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-03-17 |