MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2015-03-02 for PINN CAN BONE SCREW 6.5MMX25MM 121725500 manufactured by Depuy International Ltd 8010379.
[5478767]
Patient revised to address elevated ion levels. The cup came loose and the screw broke behind the cup.
Patient Sequence No: 1, Text Type: D, B5
[13002555]
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. 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
[26148256]
The complaint states patient revised to address elevated ion levels. The cup came loose and the screw broke behind the cup. A review of complaints database and manufacturing records did not identify any anomalies. No device associated with this report was received for examination. 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. The complaint shall be closed with an undetermined conclusion; it will be entered into the complaint database and monitored through trend analysis. Depuy considers the investigation closed at this time. Should the product and/or additional information be received, the investigation will be re-opened.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2015-14961 |
| MDR Report Key | 4560604 |
| Report Source | 05,08 |
| Date Received | 2015-03-02 |
| Date of Report | 2015-02-03 |
| Date of Event | 2015-02-03 |
| Date Mfgr Received | 2015-03-30 |
| Device Manufacturer Date | 2002-04-11 |
| Date Added to Maude | 2015-03-02 |
| 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 | 0 |
| Event Location | 0 |
| 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 | DEPUY INTERNATIONAL LTD 8010379 |
| Manufacturer Street | ST. ANTHONY'S RD |
| Manufacturer City | LEEDS, LEEDS LS118 D |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LS11 8 DT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PINN CAN BONE SCREW 6.5MMX25MM |
| Generic Name | HIP OTHER IMPLANT |
| Product Code | NDJ |
| Date Received | 2015-03-02 |
| Catalog Number | 121725500 |
| Lot Number | WN3CR1213 |
| Device Expiration Date | 2007-04-11 |
| 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 INTERNATIONAL LTD 8010379 |
| Manufacturer Address | ST. ANTHONY'S RD LEEDS, LEEDS LS118 D UK LS11 8 DT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-03-02 |