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 2018-05-08 for UNKNOWN CEMENT manufactured by Smith & Nephew, Inc..
[107590610]
Patient Sequence No: 1, Text Type: N, H10
[107590611]
It was reported that a revision surgery was performed due to faulty cement and mechanism.
Patient Sequence No: 1, Text Type: D, B5
[109178445]
Patient Sequence No: 1, Text Type: N, H10
[119208388]
The associated complaint devices were not returned to be evaluated. A review of complaint history revealed no prior complaints for the listed lots. A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident. Insufficient clinically relevant supporting documentation was provided; therefore a thorough medical investigation cannot be performed. The patient impact beyond the revision itself cannot be concluded. No further medical assessment is warranted at this time. Without the actual product involved, our investigation cannot proceed. If the device or new information is received in the future, this complaint can be re-opened. No further actions are being taken at this time. We consider this investigation closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2018-00894 |
| MDR Report Key | 7494292 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-05-08 |
| Date of Report | 2018-09-04 |
| Date of Event | 2018-02-07 |
| Date Mfgr Received | 2018-05-04 |
| Device Manufacturer Date | 2011-09-01 |
| Date Added to Maude | 2018-05-08 |
| 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 | DR SARAH FREESTONE |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN CEMENT |
| Generic Name | CEMENT,BONE,PREFORMED POLYMERIC,VRBPLST |
| Product Code | OBL |
| Date Received | 2018-05-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-05-08 |