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 2020-01-20 for EPOLY RLC 36MM 10DEG SZ24 N/A EP-105894 manufactured by Zimmer Biomet, Inc..
[176081242]
(b)(4). Concomitant medical products: 650-1057 cer bioloxd option hd 36mm 2934973, 650-1066 cer opt type 1 tpr sleve 0mm 2920992, pt-116056 regen/rnglc+ ltd 56mm sz 24 240160, 010000994 g7 apical hole plug 6102385, 51-108080 tprlc 133 mp t1 pps so 8x101mm 6006745, 103532 ti low profile screw 6. 5x25mm 181420, 106024 ringloc+ replacement ring sz24 304650. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 00293 shell, 0001825034 - 2020 - 00294 hole plug, 0001825034 - 2020 - 00295 taper, 0001825034 - 2020 - 00296 screw, 0001825034 - 2020 - 00297 ring.
Patient Sequence No: 1, Text Type: N, H10
[176081243]
It was reported that patient underwent right revision and subsequently, patient underwent another revision a year and a half later due to infection. All components were removed and a cement spacer implanted. Attempts were made to obtain additional information; however, none was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2020-00298 |
| MDR Report Key | 9608265 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-01-20 |
| Date of Report | 2020-01-20 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2020-01-02 |
| Device Manufacturer Date | 2015-07-27 |
| Date Added to Maude | 2020-01-20 |
| 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 | EPOLY RLC 36MM 10DEG SZ24 |
| Generic Name | PROSTHESIS, HIP |
| Product Code | OIY |
| Date Received | 2020-01-20 |
| Model Number | N/A |
| Catalog Number | EP-105894 |
| Lot Number | 842180 |
| 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 | 2020-01-20 |