MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-04-17 for 10 MM POSTERIOR FEMORAL AUGMENT SIZE C 03-117-03101 manufactured by Zimmer Trabecular Metal Technology.
[5649884]
The pt is pursuing a product liability claim arising out of the use of the segmental articulating surface. It is reported by the pt's counsel that the pt received the implant on (b)(6) 2012 and was revised on (b)(6) 2014 due to a fracture of the component. Note that the segmental articulating surface is of zimmer (b)(4) design control. Within review of the operative notes, there is indication that the pt had an infection in the knee location but the cause of the infection is unk. The pt was also implanted with the following tm components (zimmer tmt design control): tm tibial cone (1), tm femoral augment (3), and tm femoral cone (1); however, none of the tm components were revised at the time this report was received.
Patient Sequence No: 1, Text Type: D, B5
[13245432]
A review of the implant's mfg record indicates that it was manufactured to specification. Based on the info available, the root cause of the event cannot be determined. Should additional info be obtained to further this investigation, this report shall be updated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005751028-2015-00032 |
| MDR Report Key | 4712530 |
| Report Source | 05,07 |
| Date Received | 2015-04-17 |
| Date of Report | 2015-04-17 |
| Date of Event | 2014-03-31 |
| Date Mfgr Received | 2015-03-20 |
| Device Manufacturer Date | 2011-02-01 |
| Date Added to Maude | 2015-04-22 |
| 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 | ANAND SINGH |
| Manufacturer Street | 10 POMEROY RD. |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9735760032 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 10 MM POSTERIOR FEMORAL AUGMENT SIZE C |
| Generic Name | TM POSTERIOR FEMORAL AUGMENT |
| Product Code | KWB |
| Date Received | 2015-04-17 |
| Catalog Number | 03-117-03101 |
| Lot Number | 61743170 |
| Device Expiration Date | 2016-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER TRABECULAR METAL TECHNOLOGY |
| Manufacturer Address | 10 POMEROY RD. PARSIPPANY NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-17 |