MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-28 for 9/10 ULTAMET 36MM HEADS +6 962713000 manufactured by Depuy International Ltd - 8010379.
[184373941]
Product complaint # (b)(4). Investigation summary ==> no device associated with this report was received for examination. A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution. Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Corrective action was not indicated. 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
[188818853]
(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
[188818854]
It was reported that once the 1st revision surgery was completed (it? S reported as (b)(4)). It was reported that the patient visited to the hospital in emergency on (b)(6) 2020 and it was confirmed that dissociation of the stem from the head. Thus, the 2nd revision surgery was performed on (b)(6) 2020 by replacing the head (p/n: 962713000), the liner (p/n: unknown) and it was confirmed that metallosis had occurred. The surgery was completed, and it was unknown whether there was a surgical delay or not. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-06200 |
| MDR Report Key | 9771906 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-01-31 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2014-09-19 |
| Date Added to Maude | 2020-02-28 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY INT'L LTD. 8010379 |
| Manufacturer Street | ST ANTHONYS ROAD |
| Manufacturer City | LEEDS LS118 DT |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LS11 8 DT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 9/10 ULTAMET 36MM HEADS +6 |
| Generic Name | SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS |
| Product Code | JDG |
| Date Received | 2020-02-28 |
| Catalog Number | 962713000 |
| Lot Number | 7977662 |
| 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 INTERNATIONAL LTD - 8010379 |
| Manufacturer Address | ST. ANTHONY'S ROAD LEEDS LS118DT UK LS11 8DT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-28 |