MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2018-02-19 for PINNACLE MTL INS NEUT36IDX54OD 121887354 manufactured by Depuy Orthopaedics Inc Us.
[100399226]
(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
[100399227]
Patient was revised to address pain. Metal insert replaced with a +4/36 poly and changed the head ball. Stem trunnion looked fine, surrounding tissue looked good. Put back in 1221-36-454 (+4 neutral liner) & 1365-52-000 m-spec 36 femoral head +5. Doi: 8 years ago; dor: (b)(6) 2018; unknown side. No surgical delay.
Patient Sequence No: 1, Text Type: D, B5
[104458170]
Patient Sequence No: 1, Text Type: N, H10
[119349549]
Product complaint #: (b)(4). 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. 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
[121029434]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[121029435]
Updated doi. Added lawyer in the associated contact.
Patient Sequence No: 1, Text Type: D, B5
[132564753]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[132564754]
Ppf alleges metal wear/metallosis and elevated metal ions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2018-53578 |
| MDR Report Key | 7279758 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-02-19 |
| Date of Report | 2018-01-25 |
| Date of Event | 2018-01-25 |
| Date Mfgr Received | 2019-01-03 |
| Device Manufacturer Date | 2008-11-19 |
| Date Added to Maude | 2018-02-19 |
| 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 | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | LEEDS MFG & MATERIAL WAREHOUSE |
| Manufacturer Street | ST ANTHONYS ROAD |
| Manufacturer City | LEEDS LS118DT |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LS11 8DT |
| 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 | 2018-02-19 |
| Catalog Number | 121887354 |
| Lot Number | 2774222 |
| 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 US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-02-19 |