MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-21 for PINN LNR CON +4 10D 32IDX54OD 1218-32-754 121832754 manufactured by Depuy Orthopaedics Inc Us.
[184374205]
Product complaint # (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188856787]
(b)(4). 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
[188856788]
Fracture of the constraining ring of an implanted pinnacle? Revision acetabular cup system in a condition of recurrent anterior luxations of the hip prosthesis. In 2011 primary hip-tep, after two rear luxations in 2014, revision to the above system. After a fall in (b)(6) 2019 again recurrent luxations. Now another revision in (b)(6) 2020 with fracture of the constraining ring.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-05667 |
| MDR Report Key | 9739603 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2011-06-17 |
| Date Added to Maude | 2020-02-21 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465810988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PINN LNR CON +4 10D 32IDX54OD |
| Generic Name | PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS |
| Product Code | KWZ |
| Date Received | 2020-02-21 |
| Model Number | 1218-32-754 |
| Catalog Number | 121832754 |
| Lot Number | 102265 |
| Device Expiration Date | 2016-05-31 |
| 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 | 2020-02-21 |