MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-03-22 for OFFSET TIBIAL TRAY - ILOK STEM TIB TRAY 71MM 141513 manufactured by Biomet Orthopedics.
[70622772]
(b)(4). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant products: biomet splined knee stem 20x120mm catalog 141660 lot 080920; maxim constrained left femur 65mm catalog 145232 lot 644400; maxim femoral augment 65x10mm mr/ll catalog 145362 lot 487540; maxim femoral augment 65x10mm ml/lr catalog 145352 lot 523380; maxim femoral augment 65x6mm mr/ll catalog 145342 lot 569080; maxim femoral augment 65x6mm ml/lr catalog 145332 lot 503960; biomet tibial block 10mm catalog 141763 lot 567480; biomet splined knee stem 18x120mm catalog 141658 lot 843510; biomet hip fracture femur 14x150mm catalog 162903 lot 185510; 28mm modular femoral head catalog 163662 lot 024960; ringloc bipolar acetabular shell 28x46mm catalog 11-165216 lot 941860; agc anatomic femur right 65mm catalog 152834 lot 013190. Multiple mdr reports were filed for this event, please see associated reports: 1825034-2016-04776, 1825034-2017-01832, 1825034-2017-01833, 1825034-2017-01834, 1825034-2017-01835, 1825034-2017-01836, 1825034-2017-01838, 1825034-2017-01839, 1825034-2017-01840, 1825034-2017-01841, 1825034-2017-01842, 1825034-2017-01843.
Patient Sequence No: 1, Text Type: N, H10
[70622773]
It was reported that the patient underwent a left total knee arthroplasty approximately 14 years ago and has experienced a rash as well as itching for years; the patient has allegedly tested positive for a nickel allergy. It was further reported that the patient? S left knee is also? Loose,? Which has caused falling. It was indicated that the knee is to be revised, however, no revision has been reported to date. Attempts have been made and additional information on the reported event is unavailable at this time.
Patient Sequence No: 1, Text Type: D, B5
[108384367]
This follow-up report is being submitted to relay additional information. The complaint samples were evaluated through device history record reviews and complaint history reviews and the reported event could not be confirmed. Device history record reviews were performed and no discrepancies relevant to the reported event were identified. A review of the complaint history determined that no further actions are required. Investigation results concluded that the reported allergic reaction was determined to be related to the patient? S confirmed nickel allergy. However, a definitive root cause of the ligamentous loosening could not be determined with the information 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
| Report Number | 0001825034-2017-01837 |
| MDR Report Key | 6425436 |
| Report Source | CONSUMER |
| Date Received | 2017-03-22 |
| Date of Report | 2017-07-08 |
| Date Mfgr Received | 2017-07-07 |
| Device Manufacturer Date | 2002-12-26 |
| Date Added to Maude | 2017-03-22 |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OFFSET TIBIAL TRAY - ILOK STEM TIB TRAY 71MM |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | MBV |
| Date Received | 2017-03-22 |
| Catalog Number | 141513 |
| Lot Number | 505490 |
| Device Expiration Date | 2007-12-31 |
| 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. Required No Informationntervention | 2017-03-22 |