MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-02-26 for ACETABULAR AUGMENT 02-212-20543 manufactured by Zimmer Trabecular Metal Technology.
[5486300]
It was reported that during a pt surgery on (b)(6) 2015, the doctor proceeded to open the implant packaging and observed that the outer pouch was well sealed, however, the inner pouch was found to be unsealed. There is indication that the implant was used, which is considered acceptable since the outer pouch was sealed.
Patient Sequence No: 1, Text Type: D, B5
[13125828]
Investigation is in progress.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005751028-2015-00013 |
| MDR Report Key | 4577560 |
| Report Source | 05,07 |
| Date Received | 2015-02-26 |
| Date of Report | 2015-02-26 |
| Date of Event | 2015-01-28 |
| Date Mfgr Received | 2015-01-30 |
| Device Manufacturer Date | 2011-05-01 |
| Date Added to Maude | 2015-04-02 |
| 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 | ACETABULAR AUGMENT |
| Generic Name | ACETABULAR AUGMENT |
| Product Code | KWB |
| Date Received | 2015-02-26 |
| Catalog Number | 02-212-20543 |
| Lot Number | 61783204 |
| Device Expiration Date | 2016-05-31 |
| 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 | 2015-02-26 |