MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-07 for UNKNOWN FINN EXTRACTOR N/A manufactured by Zimmer Biomet, Inc..
[92192658]
(b)(4). It is unknown if product will be returning to zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[92192659]
It was reported that during a knee procedure the extractor became cross-threaded and cold welded to the taper adaptor and the surgeon was unable to get the stem out. The surgeon ended up putting new bushings on the old taper and putting the old taper back in. Patient was re-implanted with same component due to this malfunction. Attempts have been made and additional information on the reported event is unavailable at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2017-09957 |
| MDR Report Key | 7005700 |
| Date Received | 2017-11-07 |
| Date of Report | 2017-11-22 |
| Date of Event | 2017-10-06 |
| Date Mfgr Received | 2017-11-22 |
| Date Added to Maude | 2017-11-07 |
| 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 | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNKNOWN FINN EXTRACTOR |
| Product Code | HWI |
| Date Received | 2017-11-07 |
| Model Number | N/A |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-07 |