MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-08-07 for E-POLY 40MM +3 MAXROM LNR SZ25 N/A EP-108425 manufactured by Zimmer Biomet, Inc..
[116359323]
(b)(4). Concomitant medical products: tprlc xr t1 pps 18x156mm, (b)(4), ln 2866723; selex/magnum mod hd 40mm +6, pn (b)(4), ln 527450; m/h radial solid/apx shl 58mm, pn (b)(4), ln 815950. Multiple mdr reports were filed for this event. Please see reports: 0001825034-2018-06485, 0001825034-2018-06486, 0001825034-2018-06489. The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[116359324]
It was reported that patient underwent a revision procedure due to femoral subsidence and infection approximately seven months post-implantation. All components were revised. 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 | 0001825034-2018-06492 |
| MDR Report Key | 7758707 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-08-07 |
| Date of Report | 2018-09-25 |
| Date of Event | 2014-05-05 |
| Date Mfgr Received | 2018-09-19 |
| Device Manufacturer Date | 2013-08-05 |
| Date Added to Maude | 2018-08-07 |
| 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 | E-POLY 40MM +3 MAXROM LNR SZ25 |
| Generic Name | PROSTHESIS, HIP |
| Product Code | MAY |
| Date Received | 2018-08-07 |
| Model Number | N/A |
| Catalog Number | EP-108425 |
| Lot Number | 247020 |
| Device Expiration Date | 2018-08-31 |
| 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 | 2018-08-07 |