MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,05 report with the FDA on 2015-04-24 for TM HIP IMPLANT GENERIC UNK manufactured by Zimmer Tmt.
[5770604]
It was observed in a journal article titled "short-term survival of the trabecular metal cup is similar to that of standard cups used in acetabular revision surgery. Analysis of 2,460 first-time cup revisions in the swedish hip arthroplasty register" (attached), that of the 828 patients implanted with an unknown tm hip implant (potentially tm revision shell, tm monoblock cup or tm modular cup) eight (8) patients were revised due to bone fractures. No further information was provided. Per the fda guidance draft, these patients events will be grouped into 1 mdr report based on product and similar failure type identified in the journal article.
Patient Sequence No: 1, Text Type: D, B5
[13260585]
Investigation is in progress.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005751028-2015-00039 |
| MDR Report Key | 4736642 |
| Report Source | 03,05 |
| Date Received | 2015-04-24 |
| Date of Report | 2015-04-24 |
| Date Mfgr Received | 2015-03-09 |
| Date Added to Maude | 2015-04-30 |
| 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 | TM HIP IMPLANT GENERIC |
| Generic Name | TM HIP IMPLANT GENERIC |
| Product Code | KWB |
| Date Received | 2015-04-24 |
| Catalog Number | UNK |
| Lot Number | UNK |
| 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 TMT |
| Manufacturer Address | 10 POMEROY RD. PARSIPPANY NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-04-24 |