MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-02-14 for ATTUNE MED DOME PAT CLAMP BUT 254505551 manufactured by Depuy Ireland - 9616671.
[137562118]
Product complaint #: (b)(4). 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
[137562119]
Was alerted by techs/surgeons that the medialized dome patella instruments will no longer stay engaged to metal button holder. They are asking all to be replaced. Did the patient experience a post-op device malfunction? No. Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? Unknown. Did the patient require revision surgery or hardware removal? No. Patient status/ outcome / consequences? No. Was other medical intervention (e. G. X-rays, additional procedures, prescriptions, otc, revision) required? Unknown. Is the patient part of a clinical study? Unknown. (b)(4). Device property of? None. Device in possession of? None. By checking this box i certify that all information that are known/available has been disclosed. If any new information will be made available, the additional information will be submitted through cst: true.
Patient Sequence No: 1, Text Type: D, B5
[139884990]
(b)(4). Investigation summary: the device associated with this report was not returned for evaluation. The investigation could not draw any conclusions about the reported event without the device to examine. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2019-84564 |
| MDR Report Key | 8339376 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-14 |
| Date of Report | 2019-01-29 |
| Date of Event | 2019-01-29 |
| Date Mfgr Received | 2019-03-22 |
| Date Added to Maude | 2019-02-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 1210 WARD AVENUE |
| Manufacturer City | WEST CHESTER PA 193800988 |
| Manufacturer Country | US |
| Manufacturer Postal | 193800988 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465810988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATTUNE MED DOME PAT CLAMP BUT |
| Generic Name | PATELLA HANDLE/CLAMPS |
| Product Code | HWN |
| Date Received | 2019-02-14 |
| Catalog Number | 254505551 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY IRELAND - 9616671 |
| Manufacturer Address | LOUGHBEG RINGASKIDDY CO. CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-14 |