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 2020-03-17 for PINN MAR ETO LIP LNR 32IDX54OD 122432254 manufactured by Depuy Orthopaedics Inc Us.
[183717449]
(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
[183717450]
The primary surgery was performed via tha (date of surgery was unknown). It was reported that since reduction was performed under fluoroscopy to the patient who was under general anesthesia however it was not possible, the revision surgery was performed on (b)(6) 2020 by replacing the liner (p/n: 122432254), the head (p/n: 136532320) due to dislocation. The surgery was completed, and it was unknown whether there was a surgical delay or not. The patient mentioned that probably her hip joint was twisted when she was crouched down.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-08156 |
| MDR Report Key | 9841388 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-17 |
| Date of Report | 2020-02-19 |
| Date Mfgr Received | 2020-03-27 |
| Date Added to Maude | 2020-03-17 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | 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 MAR ETO LIP LNR 32IDX54OD |
| Generic Name | PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS |
| Product Code | JDJ |
| Date Received | 2020-03-17 |
| Catalog Number | 122432254 |
| 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 US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-17 |