MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-11 for UNKNOWN PINS N/A manufactured by Biomet Orthopedics.
[72497342]
(b)(4). No devices or photos of the devices were received; therefore, the condition of the components is unknown. Additionally, visual and dimensional evaluations could not be performed. The product number and the lot number were not provided; therefore, the manufacturing date, the device history records and the field age of the device could not be determined. There is insufficient information to perform a complaint history search. A definitive root cause could not 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 report will be filed accordingly. Zimmer biomet will continue to monitor for trends. Multiple mdr reports were filed for this event please see associated reports: 0001825034-2017-02440, 0001825034-2017-02441, 0001825034-2017-02442, 0001825034-2017-02443, 0001825034-2017-02445).
Patient Sequence No: 1, Text Type: N, H10
[72497343]
A patient identified in a journal article reportedly underwent irrigation and debridement due to infection. Attempts to obtain additional information have been made; however, none has been provided and patient outcome is unknown.
Patient Sequence No: 1, Text Type: D, B5
[75749416]
This follow-up report is being submitted to relay additional information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2017-02444 |
| MDR Report Key | 6483612 |
| Date Received | 2017-04-11 |
| Date of Report | 2017-05-17 |
| Date of Event | 2016-11-15 |
| Date Mfgr Received | 2017-05-16 |
| Date Added to Maude | 2017-04-11 |
| 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 | UNKNOWN PINS |
| Generic Name | PROSTHESIS, HIP |
| Product Code | GFC |
| Date Received | 2017-04-11 |
| Model Number | N/A |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | N/A |
| 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 | 2017-04-11 |