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 2017-10-23 for PFNA BLADE PERF L90 TAN 04.027.033S manufactured by Oberdorf Synthes Produktions Gmbh.
[90029548]
Patient information is not available for reporting. This report is for unknown pfna head element/unknown lot number. Portion of the device is still implanted in the patient, another removal is planned. (b)(6). Patient code (b)(4) used for: the patient had post-operatively pain, there is no allegation of a complaint against this device; however, because this device is dwelling in the area of the reported event it cannot be disassociated from the reported adverse event. Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was not returned and no lot number was provided. Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities. If additional is obtained that was not available for the initial med-watch, the investigation will be updated as applicable, and a follow-up med-watch will be filed as appropriate 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
[90029549]
Device report from synthes on an event in (b)(6) as follows: it was reported that the patient had post-operativey pain and thought this was because of the implanted proximal femoral antirotation (pfna) implants. A planned removal surgery was performed on (b)(6) 2017 but they were unable to remove the blade (see (b)(4)). They could not remove the blade and closed the site, another removal is planned. No information available about patient condition. This complaint involves 3 parts. This report is 3 of 3 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2017-12515 |
| MDR Report Key | 6970327 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-10-23 |
| Date of Report | 2017-10-02 |
| Date Mfgr Received | 2018-05-25 |
| Device Manufacturer Date | 2014-08-19 |
| Date Added to Maude | 2017-10-23 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | WERK BETTLACH (CH) |
| Manufacturer Street | MURACHERSTRASSE 3 |
| Manufacturer City | BETTLACH 2544 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PFNA BLADE PERF L90 TAN |
| Generic Name | APPLIANCE,FIXATION,NAIL/BLADE |
| Product Code | KTW |
| Date Received | 2017-10-23 |
| Returned To Mfg | 2018-03-12 |
| Catalog Number | 04.027.033S |
| Lot Number | 9108456 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-10-23 |