MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2018-08-01 for UNKNOWN HIP ACETABULAR LINERS UNK HIP ACETABULAR LINER manufactured by Depuy Orthopaedics Inc Us.
[115718610]
(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
[115718611]
Maude report received. Depuy pinnacle liner disassociation. The polyethylene liner disassociated from the modular acetabular component. The patient returned to the operating room for revision surgery after this was noted on physical exam and radiographic imaging. Doi: (b)(6) 2015; dor: (b)(6) 2017; unknown hip.
Patient Sequence No: 1, Text Type: D, B5
[119070804]
Product complaint #:(b)(4) investigation summary:no device associated with this report was received for examination. A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided. 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. If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2018-65575 |
| MDR Report Key | 7740173 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2018-08-01 |
| Date of Report | 2018-07-06 |
| Date of Event | 2017-01-11 |
| Date Mfgr Received | 2018-08-28 |
| Date Added to Maude | 2018-08-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465820988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465820988 |
| Manufacturer Phone | 5743725905 |
| 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 | UNKNOWN HIP ACETABULAR LINERS |
| Generic Name | HIP ACETABULAR LINERS |
| Product Code | OVO |
| Date Received | 2018-08-01 |
| Catalog Number | UNK HIP ACETABULAR LINER |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS INC US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465820988 US 465820988 |
| Brand Name | UNKNOWN HIP ACETABULAR LINERS |
| Generic Name | HIP ACETABULAR LINERS |
| Product Code | JDI |
| Date Received | 2018-08-01 |
| Catalog Number | UNK HIP ACETABULAR LINER |
| 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 465820988 US 465820988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-01 |