MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-01 for REF THREE HOLE SHELL 56MM 71336456 manufactured by Smith & Nephew, Inc..
[109886444]
Patient Sequence No: 1, Text Type: N, H10
[109886445]
It was reported that a revision sugery was performed due to damaged liner. Liner and cup were removed.
Patient Sequence No: 1, Text Type: D, B5
[132631002]
The associated complaint devices were returned and evaluated. A visual inspection of the damage and exposure of the zr2. 5nb substrate were observed on the femoral head. The acetabular liner exhibited a fracture around roughly 50% for the liner rim. The rim fragment was returned. Additional damage opposite the rim fragment was observed, which was likely due to impingement with the femoral stem neck. Dark discoloration, possibly caused by deposits of metallic debris from the damage head were observed on the face of the poly liner. Yellowish discoloration, likely caused by absorption of biological fluid observed on the backside of the liner. Faint witness of screw hole patterns could be seen. The porous bead coating on of the metal shell revealed burnished areas indicating potential movement of the shell against the acetabular bone. The clinical/medical team concluded, based on the available information the root cause for the components damage cannot be concluded but impingement and/or edge loading cannot be ruled out. However, as the implantation date is not known and no clinical/medical documents were provided, the age of the prosthesis and/or trauma or over use cannot be ruled out. ? No information on the current status of the patient has been forthcoming. A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes. A review of complaint history for the parts revealed no prior complaints for the listed batches. Based on this investigation, the need for corrective action is not indicated. No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary. Should additional information be received, the complaint will be reopened. We consider this investigation closed. Credit will not be issued for the devices.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2018-01024 |
| MDR Report Key | 7562941 |
| Date Received | 2018-06-01 |
| Date of Report | 2018-06-01 |
| Date of Event | 2018-05-24 |
| Date Mfgr Received | 2018-05-25 |
| Device Manufacturer Date | 2012-08-12 |
| Date Added to Maude | 2018-06-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 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 | 0 |
| Brand Name | REF THREE HOLE SHELL 56MM |
| Generic Name | ULTRASOUND, SINUS |
| Product Code | LWI |
| Date Received | 2018-06-01 |
| Catalog Number | 71336456 |
| Lot Number | 12HM06527 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Required No Informationntervention; 2. Deathisabilit | 2018-06-01 |