MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-30 for PINN BANTAM W/GRIPTION 46MM 1217-30-046 121730046 manufactured by Depuy Orthopaedics Inc Us.
[186004486]
(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
[186004487]
It was reported that the cup was implanted on (b)(6) 2013. The liner and head were implanted on (b)(6) 2019. Yesterday we removed the cup, head, and liner. The head and liner looked perfect but the shell had a hole worn all the way through. The hole was between 1/2? -3/4? In size. They weren't able to remove the stem so we implanted a bipolar head instead of using a prostalac stem for a stage 1 revision. Doi: (b)(6) 2013, (cup). Doi: (b)(6) 2019, (liner and head). Dor: (b)(6) 2020, affected site: unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09606 |
| MDR Report Key | 9899234 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-03-13 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2013-08-16 |
| Date Added to Maude | 2020-03-30 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 US |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465820988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465820988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PINN BANTAM W/GRIPTION 46MM |
| Generic Name | PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS |
| Product Code | LPH |
| Date Received | 2020-03-30 |
| Model Number | 1217-30-046 |
| Catalog Number | 121730046 |
| Lot Number | 415171 |
| 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 | 2020-03-30 |