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 2018-06-12 for E-POLY 32MM +3 MAXROM LNR SZ22 N/A EP-108222 manufactured by Zimmer Biomet, Inc..
[110809810]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: item # 106022, locking ring, lot # 666530. Item # 16-104146, cup, lot # 640690. Item # xl-108222, liner, lot # 696150. Item # 103531, bone screw, lot # 063030. Item # 103533, bone screw, lot # 064250. Item # 163667, femoral head, lot # 824420. Item # 51-108080, femoral stem, lot # 3275307. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-03932, 0001825034-2018-03934, 0001825034-2018-03935.
Patient Sequence No: 1, Text Type: N, H10
[110809811]
It was reported that during an initial hip procedure, a cup was implanted. The surgeon was unable to get multiple liners to seat in the implanted cup. An attempt was made using an alternate locking ring, which was also unsuccessful. All acetabular components were removed and replaced with competitor product. The device malfunction caused a surgical delay of one hour. Attempts have been made, and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-03933 |
| MDR Report Key | 7592880 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-06-12 |
| Date of Report | 2018-08-08 |
| Date of Event | 2018-05-01 |
| Date Mfgr Received | 2018-08-01 |
| Device Manufacturer Date | 2017-04-21 |
| Date Added to Maude | 2018-06-12 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | E-POLY 32MM +3 MAXROM LNR SZ22 |
| Generic Name | HIP PROSTHESIS |
| Product Code | MAY |
| Date Received | 2018-06-12 |
| Model Number | N/A |
| Catalog Number | EP-108222 |
| Lot Number | 274340 |
| ID Number | (01) 0 0880304 46908 2 |
| 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. Required No Informationntervention | 2018-06-12 |