MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-03-26 for CUSTOM RS FEMORAL AXLE N/A CP114886 manufactured by Zimmer Biomet, Inc..
[103516510]
(b)(4). Medical product - 9mm short cps anchor plug catalog# cp561286 lot# 375920, 16cm rs lt screw exp catalog# cp114882 lot# 367190, 47x14x70mm avl tibia catalog# cp114885 lot# 367070, cps transverse pin 6pk 20mm catalog# 178524 lot# 332470, 30mm 400lb shrt cps spdl catalog# cp114881 lot# 366980, custom avl tibial bushing set catalog# cp111207 lot# 536990, cps nut co-cr-mo alloy catalog# 178512 lot# 964120, oss poly lock pin catalog# 150478 lot# 695070, custom avl lock ring set of 2 catalog# cp111215 lot# 537020, cust rs avl tib brng set catalog# cp114883 lot# 537050, cust rs avl yoke set catalog# cp114884 lot# 537030, cust rs fem bshg set catalog# cp114887 lot# 573140. Reported event was unable to be confirmed due to limited information received from the customer. Dhr was reviewed and no discrepancies were found. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends
Patient Sequence No: 1, Text Type: N, H10
[103516831]
It was reported that patient had an initial left arthroplasty on unknown date. Subsequently, the surgeon is requesting a distal femur expandable implant to tibia for a planned revision due to unknown reasons.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-02211 |
| MDR Report Key | 7371364 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-03-26 |
| Date of Report | 2018-03-26 |
| Date Mfgr Received | 2018-03-23 |
| Device Manufacturer Date | 2014-09-29 |
| Date Added to Maude | 2018-03-26 |
| 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 | 3 |
| Brand Name | CUSTOM RS FEMORAL AXLE |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | KWH |
| Date Received | 2018-03-26 |
| Model Number | N/A |
| Catalog Number | CP114886 |
| Lot Number | 573110 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2018-03-26 |