MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2017-03-24 for BIOMET PRIMARY TIBIAL PLATE WITH LOCKING BAR 83MM INTERLOK 141216 manufactured by Biomet Orthopedics.
[70857699]
(b)(4). Concomitant medical products: biomet modular finned stem with screw 80 mm item #:141320 lot #: 683040. Foreign report source: (b)(6). Customer has not indicated if product is to be returned. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated report: 0001825034-2017-02095.
Patient Sequence No: 1, Text Type: N, H10
[70857700]
It was reported that a patient underwent a revision surgery due to a fracture of the implanted component connection of the modular tibial plate and stem. Attempts have been made and additional information on the reported event is unavailable.
Patient Sequence No: 1, Text Type: D, B5
[76089763]
This follow-up report is being submitted to relay additional information. Concomitant medical products- biomet modular finned stem with screw 80 mm item #:141320, lot #: 683040; optipac bone cement catalog unknown lot unknown.
Patient Sequence No: 1, Text Type: N, H10
[76089764]
It was reported that a patient underwent a revision surgery due to loosening of the tibial baseplate, during which it was noticed that the connection of the modular tibial plate and stem was fractured. Attempts have been made and additional information on the reported event is unavailable.
Patient Sequence No: 1, Text Type: D, B5
[110966291]
This follow-up report is being submitted to relay additional information. No devices were received; therefore the condition of the components is unknown. Review of dhr for the parts determined that there were no anomalies and deviations for these parts and lot combination. Review of the complaint history determined that no further action is required. X-ray evaluation report from mmi state that the images taken in the initial postop phase and at 8 months show intact hardware which is normally aligned besides the tibial stem/cone, which is positioned eccentrically lateral within the tibia (the tip of the stem approximates the endosteum). At 31 months, a newly apparent nondisplaced fracture has appeared within the cone connector within the tibia. It is not certain, but it is possible that the positioning of the cone within the tibia could have contributed to stresses on the system that led to the fracture. The remainder of the hardware is intact. Without the opportunity to examine the complaint product, root cause cannot be determined. There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation. 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
| Report Number | 0001825034-2017-02096 |
| MDR Report Key | 6434182 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2017-03-24 |
| Date of Report | 2017-09-21 |
| Date of Event | 2017-02-15 |
| Date Mfgr Received | 2017-09-21 |
| Device Manufacturer Date | 2013-10-16 |
| Date Added to Maude | 2017-03-24 |
| 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 | BIOMET ORTHOPEDICS |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOMET PRIMARY TIBIAL PLATE WITH LOCKING BAR 83MM INTERLOK |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | MBV |
| Date Received | 2017-03-24 |
| Catalog Number | 141216 |
| Lot Number | 717370 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-03-24 |