MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2008-04-02 for ZIMMER SEGMENTAL SYSTEM ARTICULAR SURFACE WITH SEGMENTAL HINGE POST 00585003012 manufactured by Zimmer, Inc..
[19155254]
It is reported that during surgery in 2008, the surgeon implanted the segmental distal femur by using a different technique. The segmental set screw portion of the segmental distal femur assembly was then threaded and tightened into the opposite side (from the side that the hinge pin was inserted) of the segmental distal femur implant, instead of behind the threaded portion of the hinge pin as indicated in the segmental surgical technique. During revision surgery, it was noted that the femoral component was rotating freely because there was too much laxity in the flexion/extension gaps. The device was revised, where a new polyethylene insert was implanted which resolved the issue. Explant date is unknown.
Patient Sequence No: 1, Text Type: D, B5
[19326811]
Device was implanted using a different surgical technique than that recommended in the zimmer segmental system surgical technique. The standard zimmer segmental system surgical technique indicates to "insert the segmental hinge pin set screw on the same side as the hinge pin," shows this orientation of the femoral assembly with the set screw inserted behind the threaded portion of the hinge pin. The standard technique was deviated from by the surgeon by placing the set screw on the contralateral side of the implant. Verification testing of this device was for an assembly with the set screw inserted on the same side as the hinge pin, thus the configuration implanted in this complaint was not tested. Therefore, it is an issue of the surgical technique not being followed. No product was returned. Review of the device history records did not find any deviations or anomalies. It is not suspected that the product failed to meet specifications. The investigation could not verify or identify any evidence of product contribution to the reported problem. Based on the investigation, the need for corrective action is not indicated. Should additional substantive information be received, the complaint will be reopened. Zimmer considers the investigation closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2008-00147 |
| MDR Report Key | 1024744 |
| Report Source | 05,08 |
| Date Received | 2008-04-02 |
| Date of Report | 2008-03-03 |
| Date of Event | 2008-02-12 |
| Date Facility Aware | 2008-03-03 |
| Report Date | 2008-03-03 |
| Date Mfgr Received | 2008-03-03 |
| Device Manufacturer Date | 2007-11-01 |
| Date Added to Maude | 2008-04-09 |
| 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 | ANN RECHTENWALL |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 5743718028 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZIMMER SEGMENTAL SYSTEM ARTICULAR SURFACE WITH SEGMENTAL HINGE POST |
| Generic Name | KNEE PROSTHESIS |
| Product Code | HRZ |
| Date Received | 2008-04-02 |
| Model Number | NA |
| Catalog Number | 00585003012 |
| Lot Number | 60699619 |
| ID Number | NA |
| Device Expiration Date | 2015-10-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 991816 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | P.O. BOX 708 WARSAW IN 465810708 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2008-04-02 |