MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-02-25 for PINN LNR CON +4 10D 28IDX50OD 1218-28-750 121828750 manufactured by Depuy Orthopaedics Inc Us.
[182288208]
Product complaint # (b)(4). Its employees caused or contributed to the potential event described in this report. (b)(4). Initial reporter occupation: lawyer. Investigation summary: no device associated with this report was received for examination. 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. Depuy considers the investigation closed. 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
[182288209]
Ppf and sticker sheets received. There were no allegations reported however the patient was revised and the reason for revision was not provided. On 24 jul 2019, pc has been re-opened due to receipt of unf and medical records. After review of medical records, the patient was revised for failed left acetabular component, multiple surgeries by other surgeon. It reported that the patient had re-dislocated and broke the liner. Operative notes reported that there was abundant metallic stained synovium debrided with electrocautery and rongeur down to the femoral prosthesis which had a large notch in the posterior aspect of the neck indicating impingement on the metal socket from anteversion of that acetabular component. Evaluation of the acetabular component revealed that it was basically completely uncovered with bone along the posterior half of the entire socket. It was just hanging on some anterior bony ingrowth. The bone defect was remarkable. Cup has been added to the complaint. Doi: (b)(6) 2015. Dor: (b)(6) 2017, (left hip, third revision).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-05900 |
| MDR Report Key | 9750582 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-02-25 |
| Date of Report | 2019-09-23 |
| Date of Event | 2017-12-21 |
| Date Mfgr Received | 2020-02-09 |
| Device Manufacturer Date | 2015-03-12 |
| Date Added to Maude | 2020-02-25 |
| 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 | 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 28IDX50OD |
| Generic Name | PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS |
| Product Code | KWZ |
| Date Received | 2020-02-25 |
| Model Number | 1218-28-750 |
| Catalog Number | 121828750 |
| Lot Number | 634579 |
| Device Expiration Date | 2020-02-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-02-25 |