MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-01-07 for TM ACETABULAR AUGMENT 02-212-10583 manufactured by Zimmer Tmt.
[5165666]
It was reported that prior to surgery, the inside packaging of the implant was found to be open and the external packaging was also damaged. The device was not used. There was also no patient impact to the patient as a replacement device was used.
Patient Sequence No: 1, Text Type: D, B5
[12714726]
Investigation is in progress.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005751028-2015-00001 |
| MDR Report Key | 4418921 |
| Report Source | 05 |
| Date Received | 2015-01-07 |
| Date of Report | 2015-01-07 |
| Date of Event | 2014-12-03 |
| Date Mfgr Received | 2014-12-10 |
| Device Manufacturer Date | 2010-06-01 |
| Date Added to Maude | 2015-01-28 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TM ACETABULAR AUGMENT |
| Generic Name | TM ACETABULAR AUGMENT |
| Product Code | KWB |
| Date Received | 2015-01-07 |
| Catalog Number | 02-212-10583 |
| Lot Number | 61532943 |
| Device Expiration Date | 2015-06-30 |
| 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 | 2015-01-07 |