MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2015-06-16 for ATTUNE FEMORAL IMPACTOR 254401006 manufactured by Depuy Orthopaedics, Inc..
[15234728]
The impactor broke during impaction.
Patient Sequence No: 1, Text Type: D, B5
[15251616]
This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[23745373]
Conclusion and justification status: the complaint states the impactor broke during impaction. The investigation confirmed that the impactor had broken as reported. Expert opinion indicates that the failures are associated with environmental stress cracking (esc). The attune femoral impactor has been annealed to reduce residual stresses. Lab tests indicate significant reduction in residual stresses of annealed samples in comparison to un-annealed samples however a complete reduction in stresses is not achievable. The annealed product was released on 30-jul-2014. This device is from an un-annealed batch. A field safety notice was issued in nov 2014 stating to reduce the possibility of leaving fragments in patients, the company suggests adhering to the instructions for use (ifu), which include inspecting the impactor? S to ensure that no instruments or pieces of instruments are left in the surgical site prior to closure. It should be noted that (b)(4) has been initiated and can be referenced for further details. The complaint shall be closed with a justified conclusion; it will be entered into the complaint database and monitored through trend analysis. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2015-23734 |
| MDR Report Key | 4848452 |
| Report Source | 05,08 |
| Date Received | 2015-06-16 |
| Date of Report | 2015-06-02 |
| Date of Event | 2015-06-02 |
| Date Mfgr Received | 2015-06-29 |
| Device Manufacturer Date | 2013-06-25 |
| Date Added to Maude | 2015-06-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEVE DOWELL |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743714918 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATTUNE FEMORAL IMPACTOR |
| Generic Name | KNEE INSTRUMENT/TRIAL |
| Product Code | LHX |
| Date Received | 2015-06-16 |
| Returned To Mfg | 2015-06-15 |
| Catalog Number | 254401006 |
| Lot Number | 3357853 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-16 |