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 2020-01-23 for POLY LINER PLUS 3 MM OFFSET 40 MM DIAMETER N/A 00434904003 manufactured by Zimmer Biomet, Inc..
[186531206]
(b)(4). 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 is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[186531207]
It was reported that during a reverse shoulder revision while inserting the liner, it was properly lined up the humeral spacer and impacted. However, the liner was not seating properly, it was not flush against the spacer. The surgeon showed the gap by fitting a thick blade in between. The surgeon then attempted to impact further and still was not able to seat the liner flush against the spacer. The liner was removed and a new liner was impacted, which fully seated flush against the spacer with no gap in between. No impact to the patient or surgery was noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2020-00246 |
| MDR Report Key | 9622043 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-01-23 |
| Date of Report | 2020-03-20 |
| Date of Event | 2019-12-20 |
| Date Mfgr Received | 2020-03-20 |
| Device Manufacturer Date | 2017-09-11 |
| Date Added to Maude | 2020-01-23 |
| 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 | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLY LINER PLUS 3 MM OFFSET 40 MM DIAMETER |
| Generic Name | PROSTHESIS SHOULDER |
| Product Code | KWT |
| Date Received | 2020-01-23 |
| Returned To Mfg | 2020-01-13 |
| Model Number | N/A |
| Catalog Number | 00434904003 |
| Lot Number | 63733985 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-01-23 |