MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-06 for ZIMMER PATELLOFEMORAL TROCHLEAR COMPONENT N/A 00592601402 manufactured by Zimmer, Inc..
[44805935]
No device or photographs were with the complaint for an evaluation; therefore, a visual an physical examination on the condition of the device was not possible. Device history records review was performed with no issues noted. The device was used for treatment. A product history search did not reveal any other complaints against the related part and lot combination. The low density polyethylene (ldpe) adhesion issue has been investigated and addressed by corrective and preventative action. A risk assessment indicates that the likelihood of a toxic effect from the ldpe bags is negligible. Zimmer has done testing that shows the residue can be removed with a cloth moistened with water or isopropyl alcohol. The lot was manufactured prior to corrective and preventive actions taken. Field action (b)(4) 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. Implanted in patient.
Patient Sequence No: 1, Text Type: N, H10
[44805936]
It was reported that polyethylene wrap adhered to the implant and was noted melted on several sides of the implant. The hospital team had difficulty removing the plastic from the implant but with some water & instruments, they were able to remove the polythene wrap and implant the component.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2016-01464 |
| MDR Report Key | 5636900 |
| Date Received | 2016-05-06 |
| Date of Report | 2015-03-16 |
| Date of Event | 2015-03-16 |
| Date Mfgr Received | 2015-03-16 |
| Device Manufacturer Date | 2012-05-31 |
| Date Added to Maude | 2016-05-06 |
| 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 | MS. CARRIE SCHNEIDER |
| 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 | 1800 WEST CENTER STREET |
| Manufacturer City | WARSAW IN 46580 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46580 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0845-2016 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ZIMMER PATELLOFEMORAL TROCHLEAR COMPONENT |
| Generic Name | KRR |
| Product Code | KRR |
| Date Received | 2016-05-06 |
| Model Number | N/A |
| Catalog Number | 00592601402 |
| Lot Number | 62062029 |
| ID Number | N/A |
| 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 | 1800 WEST CENTER STREET WARSAW IN 46580 US 46580 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-06 |