MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2019-03-13 for EXCEED ABT E1 N/FLNG CUP 36X54 N/A EP-113654 manufactured by Biomet Uk Ltd..
[138647979]
(b)(4). Concomitant medical products:medical product: delta ceramic fem hd 36/-3mm, catalog #: 650-0660, lot #: not reported. Report source, foreign - event occurred in (b)(6). Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00267. Reported event was unable to be confirmed due to limited information received from the customer. Dhr review was unable to be performed as the lot number of the device involved in the event is unknown. 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. Product not returned.
Patient Sequence No: 1, Text Type: N, H10
[138647980]
The (b)(6) reported that a patient underwent an initial right hip arthroplasty. Subsequently, a revision procedure was performed due to unknown reason. Cup and head were revised.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002806535-2019-00268 |
| MDR Report Key | 8415642 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2019-03-13 |
| Date of Report | 2019-03-13 |
| Date of Event | 2015-11-11 |
| Date Mfgr Received | 2019-02-14 |
| Date Added to Maude | 2019-03-13 |
| 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 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 | EXCEED ABT E1 N/FLNG CUP 36X54 |
| Generic Name | HIP PROSTHESIS |
| Product Code | JDD |
| Date Received | 2019-03-13 |
| Model Number | N/A |
| Catalog Number | EP-113654 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| 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. Hospitalization; 2. Required No Informationntervention | 2019-03-13 |