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 2020-03-23 for CR PROLONG 40MM BRNG STD NI 110031421 manufactured by Zimmer Biomet, Inc..
[186742883]
(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01212. Product code: phx. Concomitant medical products: 25mm versa-dial taper adaptor part#118000-00 lot#957120. Cr 40mm glenosphere std cocr part#110030776 lot#64316096. Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[186742884]
It was reported that patient underwent a revision procedure three months post implantation due to the right the poly bearing disassociating from the tray. The bearing and tray were removed and replaced. No further information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2020-01211 |
| MDR Report Key | 9865652 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-23 |
| 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 | NI |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CR PROLONG 40MM BRNG STD |
| Generic Name | PROSTHESIS, EXTREMITIES |
| Product Code | PHX |
| Date Received | 2020-03-23 |
| Returned To Mfg | 2020-03-05 |
| Model Number | NI |
| Catalog Number | 110031421 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-23 |