MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-04-13 for TRABECULAR METAL REVISION SHELL, 60MM 02-210-00603 manufactured by Zimmer Trabecular Metal Technology.
[5677961]
The patient is pursuing a product liability claim arising out of the use of the acetabular revision shell. It is reported by the patient's counsel that the patient received a tha on (b)(6) 2005 and was revised using the acetabular revision shell on (b)(6) 2012 due to loosening of the shell/cup. It was also reported that the patient had complications with metallosis, but the acetabular revision shell is not indicated for use with a metal on metal insert.
Patient Sequence No: 1, Text Type: D, B5
[13134163]
A review of the implant's manufacturing record indicates that it was manufactured to specification. Based on the information available, the root cause of the event cannot be determined. Should additional information be obtained to further this investigation, this report shall be updated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005751028-2015-00029 |
| MDR Report Key | 4698695 |
| Report Source | 05,07 |
| Date Received | 2015-04-13 |
| Date of Report | 2015-04-13 |
| Date of Event | 2013-09-04 |
| Date Mfgr Received | 2015-03-17 |
| Device Manufacturer Date | 2004-08-01 |
| Date Added to Maude | 2015-04-17 |
| 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 | TRABECULAR METAL REVISION SHELL, 60MM |
| Generic Name | TM REVISION SHELL |
| Product Code | KWB |
| Date Received | 2015-04-13 |
| Catalog Number | 02-210-00603 |
| Lot Number | 56465216 |
| Device Expiration Date | 2009-08-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Required No Informationntervention | 2015-04-13 |