MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-17 for S-ROM*ADAPTOR HUDSON TO ZIMMER 530302 manufactured by Depuy Orthopaedics, Inc..
[34370211]
(b)(4). 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
[34370212]
The adapter broke where it mates with our instrumentation. Two others have begun to fracture in the same area.
Patient Sequence No: 1, Text Type: D, B5
[34895647]
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
[36373809]
Examination of the returned instruments confirms the observation. The adaptor exhibits fracture initiation to its tab on two of the instruments and a full tab fracture is present on the third. Previous evaluations found misuse and heavy usage as contributing factors. If used with reamers that have begun to wear on the reamer hudson attachment ends/flats, the worn reamers can rotate within the end of the instrument and facilitate a spreading/tearing of the tabs as well. Based on the investigation, the need for corrective action is not indicated. Continue to monitor through trend analysis (b)(4). Depuy considers the investigation closed. 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 | 1818910-2015-37657 |
| MDR Report Key | 5306094 |
| Date Received | 2015-12-17 |
| Date of Report | 2015-11-23 |
| Date of Event | 2015-11-23 |
| Date Mfgr Received | 2016-01-19 |
| Device Manufacturer Date | 2012-11-09 |
| Date Added to Maude | 2015-12-17 |
| 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 | CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. |
| 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 | S-ROM*ADAPTOR HUDSON TO ZIMMER |
| Generic Name | HIP INSTRUMENT/TRIAL |
| Product Code | LHX |
| Date Received | 2015-12-17 |
| Returned To Mfg | 2015-12-22 |
| Catalog Number | 530302 |
| Lot Number | SO2006627 |
| 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 | 2015-12-17 |