MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-03-25 for MODULAR FEMORAL STEM CALCICOAT CERAMIC COATING SIZE 9 N/A 65771300900 manufactured by Zimmer Biomet, Inc..
[186509484]
(b)(4). Concomitant medical products: 00784801300 m/l kinectiv strt neck p 61269206, 0100181500 durom metasul hd 50 cde p 2472890, 0100185146 hd adapt m/0 12/14 18/20 2514226, 0100214056 durom cup 56/p 289 2477612. Report source: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation. The product was retained by the hospital and it's location is unknown. 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
[186509485]
It was reported the patient underwent an initial tha and was revised ten years later due to pain and femoral stem fracture. Attempts were made to obtain additional information; however, none was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2020-00951 |
| MDR Report Key | 9880394 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-03-25 |
| Date of Report | 2020-04-03 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-31 |
| Device Manufacturer Date | 2010-06-21 |
| Date Added to Maude | 2020-03-25 |
| 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 | MODULAR FEMORAL STEM CALCICOAT CERAMIC COATING SIZE 9 |
| Generic Name | PROSTHESIS, HIP |
| Product Code | MEH |
| Date Received | 2020-03-25 |
| Model Number | N/A |
| Catalog Number | 65771300900 |
| Lot Number | 61487872 |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-03-25 |