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 2020-03-29 for ACT ARTIC E1 HIP BRG 28X44MM N/A EP-200150 manufactured by Zimmer Biomet, Inc..
[186544907]
(b)(4). Concomitant medical products: biomet liner cat#110024464 lot#776200 zimmer head cat#00801802803 lot#64482573 unknown cup. The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[186544908]
It was reported a patient underwent hip arthroplasty. Approximately 2 weeks later patient went to sit down and twisted back and felt a pop. The patient was reduced, but it was just the metal head in the cup sans poly. When the surgeon opened him up, the poly was disassociated from the femoral head. The surgeon felt the implants were acceptable. The implants were reassembled and the hip reduced. Attempts have been made and additional information on the reported event is unavailable at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2020-01290 |
| MDR Report Key | 9895058 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-03-29 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-29 |
| 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 | ACT ARTIC E1 HIP BRG 28X44MM |
| Generic Name | PROSTHESIS, HIP |
| Product Code | OQG |
| Date Received | 2020-03-29 |
| Model Number | N/A |
| Catalog Number | EP-200150 |
| Lot Number | 875270 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-03-29 |