MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2016-04-12 for GENDER SOLUTIONS PFJ TROCHLEA COMPONENT 00592601501 manufactured by Zimmer Inc,.
[42496518]
The product was implanted; therefore, it was not available for return or evaluation. The device was used for treatment. This issue has been previously investigated and as part of corrective action, a new supplier for the polyethylene bags has been selected and testing completed to ensure thermal reliability and stability of the new bags. Field action z-0845-2016 was initiated on january 11, 2016 to remove remaining affected units from the field. This field action contains the related part and lot number. This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.
Patient Sequence No: 1, Text Type: N, H10
[42496519]
It was reported that the inner plastic bag packaging was stuck to the implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1822565-2016-01051 |
| MDR Report Key | 5572642 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2016-04-12 |
| Date of Report | 2014-10-06 |
| Date of Event | 2014-10-02 |
| Date Mfgr Received | 2014-10-06 |
| Date Added to Maude | 2016-04-12 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | KEVIN ESCAPULE |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 8006136131 |
| Manufacturer G1 | ZIMMER INC |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465810708 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0845-2016 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GENDER SOLUTIONS PFJ TROCHLEA COMPONENT |
| Generic Name | KRR |
| Product Code | KRR |
| Date Received | 2016-04-12 |
| Catalog Number | 00592601501 |
| Lot Number | 77001690 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER INC, |
| Manufacturer Address | P.O. BOX 708 WARSAW IN 465810708 US 465810708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-12 |