MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,05 report with the FDA on 2014-10-21 for PROXILOCK GENERIC (TMT) UNK manufactured by Zimmer Tmt.
[4967286]
It was reported in a journal article for clinical orthopaedics and related research, title "increased risk of periprosthetic femur fractures associated with a unique cementless stem design (manuscript draft)", number (b)(4), that 39 patients were implanted with the proxilock femoral component during a primary tha and were identified to have a periprosthetic fracture, post-op. Five/thirty nine patients had internal fixation, 25/39 patients had stem revisions and for the remaining 9/39 patients, no information was provided. Additionally, no further patient information was available at this time.
Patient Sequence No: 1, Text Type: D, B5
[12401545]
Review of journal article and investigation is in progress.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005751028-2014-00086 |
| MDR Report Key | 4209678 |
| Report Source | 03,05 |
| Date Received | 2014-10-21 |
| Date of Report | 2014-10-21 |
| Date Mfgr Received | 2014-09-24 |
| Date Added to Maude | 2014-10-30 |
| 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 | PROXILOCK GENERIC (TMT) |
| Generic Name | PROXILOCK |
| Product Code | GFI |
| Date Received | 2014-10-21 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER TMT |
| Manufacturer Address | 10 POMEROY RD. PARSIPPANY NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-10-21 |