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 2018-02-16 for PINNACLE MTL INS NEUT36IDX54OD 121887354 manufactured by Depuy Orthopaedics, Inc. 1818910.
[100247244]
(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
[100247245]
Der states that the patient had a depuy ceramic on metal tha approximately 10 years ago patient was painful. Surgeon removed the pinnacle ultimate liner and corail stem with a ceramic head. Surgeon replaced pinnacle poly liner into retained pinnacle cup size 54. Surgeon place a new corail revision stem with a new ceramic head. It was also reported that there was non-cemented loosening interface. Doi: approximately 10 years ago. Dor: (b)(6) 2018; left hip.
Patient Sequence No: 1, Text Type: D, B5
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(b)(4). No device associated with this report was received for examination. A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution. Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications. 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 will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2018-53511 |
| MDR Report Key | 7276290 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-02-16 |
| Date of Report | 2018-01-23 |
| Date of Event | 2018-01-23 |
| Date Mfgr Received | 2018-03-09 |
| Device Manufacturer Date | 2008-06-05 |
| Date Added to Maude | 2018-02-16 |
| 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 | 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 INTERNATIONAL LTD. 8010379 |
| Manufacturer Street | ST. ANTHONY'S RD |
| Manufacturer City | LEEDS LS118 DT |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LS11 8 DT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PINNACLE MTL INS NEUT36IDX54OD |
| Generic Name | HIP METAL ACETABULAR LINERS |
| Product Code | OVO |
| Date Received | 2018-02-16 |
| Catalog Number | 121887354 |
| Lot Number | 2641413 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465820988 US 465820988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-02-16 |