MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-06-11 for CERAMIC manufactured by Smith & Nephew, Inc..
[3441100]
It was reported that revision surgery was performed.
Patient Sequence No: 1, Text Type: D, B5
[10815193]
.
Patient Sequence No: 1, Text Type: N, H10
[11141850]
Based on the received information (x-rays, surgical report of revision) a steep position of he shell in situ existed pre revision. A steep position of the shell decreases rom of the hip joint potentially resulting in impingement btween components of the prosthesis and an increased risk for subluxation of the ball head. However, it remains unclear if the position of the shell contributed to the reported incident. Based on the received information the root cause as well as the point in time when the insert breakage occured couldn't be defined conclusively.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9613369-2013-00047 |
| MDR Report Key | 3162272 |
| Report Source | 07 |
| Date Received | 2013-06-11 |
| Date of Report | 2013-05-23 |
| Date of Event | 2013-05-15 |
| Date Mfgr Received | 2013-05-23 |
| Date Added to Maude | 2013-06-12 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. MELANIE TRAVIS |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013996233 |
| Manufacturer G1 | SMITH & NEPHEW GMBH |
| Manufacturer Street | SCHACHENALLEE 29 |
| 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 | CERAMIC |
| Generic Name | CERAMIC CERAMIC INSERT STANDARD 44/36 |
| Product Code | LPF |
| Date Received | 2013-06-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | SCHACHENALLEE 29 AARAU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2013-06-11 |