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 2018-05-01 for E-POLY 36MM +3 MAXROM LINER SZ23 N/A EP-108223 manufactured by Zimmer Biomet, Inc..
[107067214]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to hospital discarding as biohazard. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: biomet regen/rnglc+ ltd 52mm sz 23, item #: pt-116052, lot#: 315700, biomet cer bioloxd mod hd 36mm std nk, item#: 12-115121, lot#: 2911053, biomet tprlc 133 fp type1 pps ho 7. 0, item#: 51-101070, lot#: 2711253. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 03017, 0001825034 - 2018 - 03018.
Patient Sequence No: 1, Text Type: N, H10
[107067215]
It was reported patient underwent a hip revision 2 days post-op due to disassociation and dislocation. No anomalies were noticed during the initial surgery, but surgeon believes patient's abnormally high body mass index was a contributing factor. No additional patient consequences were reported. Attempts to obtain additional information have been made; however, no more is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-03015 |
| MDR Report Key | 7477726 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-05-01 |
| Date of Report | 2018-05-09 |
| Date of Event | 2018-04-11 |
| Date Mfgr Received | 2018-05-08 |
| Device Manufacturer Date | 2017-07-06 |
| Date Added to Maude | 2018-05-01 |
| 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 36MM +3 MAXROM LINER SZ23 |
| Generic Name | HIP PROSTHESIS |
| Product Code | MAY |
| Date Received | 2018-05-01 |
| Model Number | N/A |
| Catalog Number | EP-108223 |
| Lot Number | 247000 |
| ID Number | 0 0880304 46909 9 |
| Operator | PHYSICIAN |
| 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 | 2018-05-01 |