MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2007-02-14 for PINNACLE 100 ACET CUP 52MM 121701052 manufactured by Depuy Orthopaedics, Inc..
[584620]
During the primary surgery, the rod on the angled inserter snapped and broke during use. The cup could not be removed from the end to the insert. Another cup was opened and used without incident. The surgery was delayed approximately 20 minutes.
Patient Sequence No: 1, Text Type: D, B5
[7943388]
This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2007-00347 |
| MDR Report Key | 819227 |
| Report Source | 05,08 |
| Date Received | 2007-02-14 |
| Date of Report | 2007-01-19 |
| Date of Event | 2007-01-19 |
| Date Mfgr Received | 2007-01-19 |
| Device Manufacturer Date | 2006-04-01 |
| Date Added to Maude | 2007-02-22 |
| 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 | 0 |
| Manufacturer Contact | GINNY STAMBERGER, MGR |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 5743727333 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581098 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 0988 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PINNACLE 100 ACET CUP 52MM |
| Generic Name | 87 LPH |
| Product Code | HXO |
| Date Received | 2007-02-14 |
| Model Number | NA |
| Catalog Number | 121701052 |
| Lot Number | AK6FF1000 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 806716 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Address | 700 ORTHOPAEDIC DR. WARSAW IN 465810988 US |
| Baseline Brand Name | PINNACLE 100 ACET CUP |
| Baseline Generic Name | POLYETHYLENE LINERS |
| Baseline Model No | NA |
| Baseline Catalog No | 121701052 |
| Baseline ID | NA |
| Baseline Device Family | PINNANCLE LINERS |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K000306 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-02-14 |