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 2017-12-18 for CEMENTRALIZER 11.0 137620000 manufactured by Depuy Orthopaedics Inc Us.
[95166786]
(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
[95166787]
Der states pt had original surgery (b)(6) 2017. On (b)(6) 2017 patient had head and liner exchange for infection. Patient still infected so surgeon removed all components and put in antibiotic spacer. It also state that patient was revised to address loosening of the femoral stem at the cement to implant interface. Unknown cement is used. Doi: (b)(6) 2017; dor: (b)(6) 2017; head and liner: (b)(6) 2017; left hip.
Patient Sequence No: 1, Text Type: D, B5
[118257631]
(b)(4). Investigation summary 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 | 1818910-2017-51852 |
| MDR Report Key | 7125127 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-12-18 |
| Date of Report | 2017-11-26 |
| Date of Event | 2017-11-26 |
| Date Mfgr Received | 2018-07-31 |
| Device Manufacturer Date | 2015-04-07 |
| Date Added to Maude | 2017-12-18 |
| 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 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS INC US |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CEMENTRALIZER 11.0 |
| Generic Name | CEMENT |
| Product Code | LTO |
| Date Received | 2017-12-18 |
| Catalog Number | 137620000 |
| Lot Number | 643332 |
| 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 | 2017-12-18 |