MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-07 for COMP RVS TRAY +5MM CO 44MM N/A 115375 manufactured by Zimmer Biomet, Inc..
[92478645]
Zimmer biomet complaint: (b)(4). Complaint sample was evaluated and the reported event was not confirmed. Product was found to be manufactured to design specifications as noted in dimensional analysis. (b)(4) was initiated based on similar complaints of assembly concerns dhr was reviewed and no discrepancies related to the reported event were found. Review of the complaint history determined that no further action is required as no trends were identified. Investigation results concluded that the reported event was due to positioning/alignment during the surgical procedure. There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation. A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device. 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
[92478646]
It was reported that the e1 poly bearing would not snap into the base.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2017-07608 |
| MDR Report Key | 7005632 |
| Date Received | 2017-11-07 |
| Date of Report | 2017-10-31 |
| Date of Event | 2014-05-27 |
| Date Mfgr Received | 2014-06-03 |
| Device Manufacturer Date | 2013-05-17 |
| Date Added to Maude | 2017-11-07 |
| 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 | 0 |
| Brand Name | COMP RVS TRAY +5MM CO 44MM |
| Generic Name | EXTREMITIES - IMPLANTS |
| Product Code | LRP |
| Date Received | 2017-11-07 |
| Returned To Mfg | 2014-06-09 |
| Model Number | N/A |
| Catalog Number | 115375 |
| Lot Number | 394180 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 1. Required No Informationntervention | 2017-11-07 |