MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-02 for ZIMMER SHOULDER CUSTOM AUGMENT 32855091032 manufactured by Zimmer Inc.
[27588126]
(b)(4). Other device used: catalog #32855091031, zimmer shoulder custom augment, lot #95006410. Only this component was returned for evaluation on 09/30/2015. This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[27588127]
It is reported that custom made augments were packaged incorrectly. A 15 degree large augment was ordered; however, a 30 degree large augment was in the box. When the 30 degree large augment box was opened, the 15 degree large augment fell out.
Patient Sequence No: 1, Text Type: D, B5
[37297519]
As returned the augment block is in like new condition, and the returned packaging material indicates a 15 degree augment. The returned augment block measures as a 30 degree device. Review of the device history records did not find any deviations or anomalies. The device was used for treatment. The investigation identified the root cause as incorrectly retrieving the program for production of the custom implants. As these are custom devices, their programs were not stored in the same manner as standard production, controlled documents. The wrong program was run for the part number. Additionally the inspection plans for custom devices consists of a marked up drawing provided by custom development. In this case the inspection dimensions cited on the drawing did not differentiate between the 15 degree and 30 degree components. Therefore, the issue was identified in inspection. As an output of this investigation, custom device programs are now placed in the same controlled location as standard production programs, and updated prints with differentiated measurements were provided for inspection. This issue resulted in a field action in australia only to retrieve the affected lots.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2015-02066 |
| MDR Report Key | 5123341 |
| Date Received | 2015-10-02 |
| Date of Report | 2015-08-27 |
| Date of Event | 2015-08-27 |
| Date Mfgr Received | 2016-01-27 |
| Device Manufacturer Date | 2015-08-12 |
| Date Added to Maude | 2015-10-02 |
| 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 | 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZIMMER SHOULDER CUSTOM AUGMENT |
| Generic Name | SHOULDER PROSTHESIS |
| Product Code | KWR |
| Date Received | 2015-10-02 |
| Catalog Number | 32855091032 |
| Lot Number | 95006411 |
| Device Expiration Date | 2015-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-10-02 |