MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-05-06 for UNKNOWN ROTATING HINGE KNEE KIT N/A manufactured by Biomet Uk Ltd..
[44609294]
The user facility is outside of the united states. Current information is insufficient to permit a conclusion as to the cause of the event. The product identification necessary to review manufacturing history was not provided. Product location unknown.
Patient Sequence No: 1, Text Type: N, H10
[44609295]
During a total knee arthroplasty, the surgeon noticed the wrong surgical kit was present in the room. The procedure was postponed indefinitely.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002806535-2016-00222 |
| MDR Report Key | 5637274 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-05-06 |
| Date of Report | 2016-04-07 |
| Date of Event | 2016-04-07 |
| Date Mfgr Received | 2016-04-07 |
| Date Added to Maude | 2016-05-06 |
| 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 | MR. DANIEL TILBURY |
| Manufacturer Street | WATERTON INDUSTRIAL ESTATES |
| Manufacturer City | BRIDGEND CF313XA |
| Manufacturer Country | UK |
| Manufacturer Postal | CF31 3XA |
| Manufacturer Phone | 0441656655 |
| Manufacturer G1 | BIOMET UK LTD. |
| Manufacturer Street | WATERTON INDUSTRIAL ESTATES |
| Manufacturer City | BRIDGEND CF313XA |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CF31 3XA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN ROTATING HINGE KNEE KIT |
| Generic Name | NI |
| Product Code | HRZ |
| Date Received | 2016-05-06 |
| Model Number | N/A |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET UK LTD. |
| Manufacturer Address | WATERTON INDUSTRIAL ESTATES BRIDGEND CF313XA UK CF31 3XA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-06 |