MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-12-01 for BIOMET STEMMED TIBIAL PLATE 75MM ? INTERLOK WITH LOCKING BAR / WITH PLUGS N/A 141514 manufactured by Biomet Orthopedics.
[61206854]
Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly or deviation. There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 4 states,? Loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption or excessive activity.? Number 15 states,? Interoperative or postoperative bone fracture and/or postoperative pain.? Concomitant medical products - agc patella arcom poly. With wire 34mm catalog 11-150828 lot 653030; bmt splined knee stm 80x20mm catalog 141620 lot 187910. This report is number 2 of 8 mdr's filed for the same patient (reference 1825034-2016-04791 / 04798).
Patient Sequence No: 1, Text Type: N, H10
[61206855]
Legal counsel for patient reported that patient underwent a right knee revision procedure approximately seven years post-implantation due to alleged pain, dysfunction, and loosening. A review of invoice history confirms tibial tray, patella, bearing and femur were removed and replaced. This report is based on allegations set forth in plaintiff? S complaint and the allegations contained therein are unverified.
Patient Sequence No: 1, Text Type: D, B5
[75742648]
Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.
Patient Sequence No: 1, Text Type: N, H10
[112231236]
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. Customer has indicated that the product will not be returned [location unknown] to zimmer biomet for investigation. Reported event was unable to be confirmed due to limited information received from the customer. Dhr was reviewed and no discrepancies relevant to the reported event were found. Review of the complaint history determined that no further action is required as no trends were identified. Root cause was unable to be determined. 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
[112231237]
Legal counsel for patient reported that patient underwent a right knee revision procedure approximately seven years post-implantation due to alleged pain, dysfunction, nickel allergy, limited range of motion and loosening of the femoral components. A review of invoice history confirms tibial tray, patella, bearing and femur were removed and replaced. Legal counsel also reported that the patient expired due to unknown reasons approximately one month post revision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2016-04792 |
| MDR Report Key | 6137813 |
| Report Source | OTHER |
| Date Received | 2016-12-01 |
| Date of Report | 2017-10-01 |
| Date of Event | 2015-07-16 |
| Date Mfgr Received | 2017-09-29 |
| Device Manufacturer Date | 2008-02-13 |
| Date Added to Maude | 2016-12-01 |
| 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 |
| Reporter Occupation | ATTORNEY |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOMET STEMMED TIBIAL PLATE 75MM ? INTERLOK WITH LOCKING BAR / WITH PLUGS |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | MBV |
| Date Received | 2016-12-01 |
| Model Number | N/A |
| Catalog Number | 141514 |
| Lot Number | 161550 |
| ID Number | N/A |
| Device Expiration Date | 2013-02-28 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-12-01 |