MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-10 for GUIDE WIRE, BALL-TIPPED, STERILE T2 TIBIA ?3X800 MM 18060080S manufactured by Stryker Trauma Kiel.
[96932464]
Device will not be returned. If additional information becomes available, it will be provided on a supplemental report. Device is not available.
Patient Sequence No: 1, Text Type: N, H10
[96932465]
It was reported that patient's left hip was revised due to periprosthetic fracture and infection. Revised components are "21+30 cone body, 20x267 plasma stem, 28 biolox head, 42e mdm insert". Rep reported that x-rays, medical records, and further information are not available due to hospital's hipaa policy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009610622-2018-00009 |
| MDR Report Key | 7180813 |
| Date Received | 2018-01-10 |
| Date of Report | 2018-07-11 |
| Date of Event | 2017-12-20 |
| Date Mfgr Received | 2018-06-14 |
| Device Manufacturer Date | 2017-08-02 |
| Date Added to Maude | 2018-01-10 |
| 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 | MR. ANNA JUSINSKI |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER TRAUMA KIEL |
| Manufacturer Street | PROF. KUENTSCHER-STRASSE 1-5 |
| Manufacturer City | SCHOENKIRCHEN/KIEL D-24232 |
| Manufacturer Postal Code | D-24232 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GUIDE WIRE, BALL-TIPPED, STERILE T2 TIBIA ?3X800 MM |
| Generic Name | INSTRUMENT |
| Product Code | MAY |
| Date Received | 2018-01-10 |
| Catalog Number | 18060080S |
| Lot Number | K0CDDAR |
| Device Expiration Date | 2017-08-02 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER TRAUMA KIEL |
| Manufacturer Address | PROF. KUENTSCHER-STRASSE 1-5 SCHOENKIRCHEN/KIEL D-24232 D-24232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-10 |