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 2015-08-26 for PIN TRL LNR NEUT +4 40ID 56OD 221840456 manufactured by Depuy Orthopaedics, Inc..
[24128185]
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
[24128186]
While trialing the liner, the middle screw snapped off where the screw is held on by the pin.
Patient Sequence No: 1, Text Type: D, B5
[26508684]
The device associated with this report was not returned. Review of the device history records and/or a lot specific complaint database search was not possible as the lot code required was not provided. Previous investigations found the user over-tightening the threaded insert during use and intentionally disassembling the snap ring from the screw for surgical preference or cleaning are suspected root causes. (b)(4) was conducted in november of 2011. The investigation did not establish the need for corrective action based on no immediate patient risk, the low frequency of reported events, and suspected customer misuse as the root cause. No evidence was found of product or design error as a contributing factor. All subsequent complaints regarding failures within the pinnacle trial liner product family will be monitored under post market surveillance sep 419. 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 | 1818910-2015-29032 |
| MDR Report Key | 5032097 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2015-08-26 |
| Date of Report | 2015-07-28 |
| Date of Event | 2015-07-28 |
| Date Mfgr Received | 2015-09-22 |
| Date Added to Maude | 2015-08-26 |
| 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 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| 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 | PIN TRL LNR NEUT +4 40ID 56OD |
| Generic Name | HIP INSTRUMENT/TRIAL |
| Product Code | LHX |
| Date Received | 2015-08-26 |
| Catalog Number | 221840456 |
| Lot Number | UNKNOWN |
| 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. |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-26 |