MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-09-22 for GII CR ART INS SZ 3-4 13MM 71420494 manufactured by Smith & Nephew, Inc..
[4718505]
It was reported that a revision surgery was performed due to loosening and wear.
Patient Sequence No: 1, Text Type: D, B5
[12411442]
Patient Sequence No: 1, Text Type: N, H10
[12754943]
The associated devices were returned and evaluated. A patella and an insert were returned. It was stated that the insert was removed during the patella revision. There was no communicated concerns with the insert. The lot number for the patella was not provided and could not be determined during our investigation; therefore a review of manufacturing records and lot complaint history was not possible. As a result our investigation could not determine the specific cause of the experienced failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2014-00578 |
| MDR Report Key | 4108350 |
| Report Source | 07 |
| Date Received | 2014-09-22 |
| Date of Report | 2014-06-11 |
| Date of Event | 2014-06-11 |
| Date Mfgr Received | 2014-06-11 |
| Date Added to Maude | 2014-09-23 |
| 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. CONNIE MCBROOM |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013995985 |
| 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 | GII CR ART INS SZ 3-4 13MM |
| Generic Name | KNEE IMPLANT |
| Product Code | HSA |
| Date Received | 2014-09-22 |
| Returned To Mfg | 2014-09-22 |
| Catalog Number | 71420494 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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. Required No Informationntervention | 2014-09-22 |