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 2017-11-29 for BIOMET OFFSET TIBIAL TRAY N/A 141482 manufactured by Zimmer Biomet, Inc..
[93289282]
(b)(4). Concomitant medical products - arcom series a patella standard # 184764 lot # 535310. Vanguard ps tibial bearing # 183624 lot # 653110. Biomet smooth knee stem # 145024 lot # 574960. Biomet offset tibial tray adaptor # 141491 lot # 470640. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-10674, 0001825034-2017-10676, 0001825034-2017-10677 and 0001825034-2017-10678. Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted in the patient. 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
[93289283]
It was reported that the patient was experiencing pain and loss of sensation in his left knee post a revision surgery.
Patient Sequence No: 1, Text Type: D, B5
[120749919]
Upon reassessment of the reported event, it was determined to not be reportable as this product was not related to the patella fracture and pain of the patient.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2017-10675 |
| MDR Report Key | 7068702 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2017-11-29 |
| Date of Report | 2018-01-15 |
| Date Mfgr Received | 2018-01-11 |
| Device Manufacturer Date | 2012-11-25 |
| Date Added to Maude | 2017-11-29 |
| 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 | BIOMET OFFSET TIBIAL TRAY |
| Generic Name | PROSTHESIS KNEE |
| Product Code | MBV |
| Date Received | 2017-11-29 |
| Model Number | N/A |
| Catalog Number | 141482 |
| Lot Number | 744940? |
| ID Number | N/A |
| Device Expiration Date | 2017-11-28 |
| 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 | 1. Other | 2017-11-29 |