MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2017-09-14 for GENDER SOLUTIONS PATELLO-FEMORAL TROCHLEA COMPONENT N/A 00592601301 manufactured by Zimmer Biomet, Inc..
[86085206]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown. 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
[86085207]
It was reported that the patient was revised to address loosening. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
[132805580]
This follow-up report is being submitted to relay additional information. The following sections were updated: concomitant devices - unknown zimmer tibial component catalog #: ni lot #: ni, unknown zimmer articular surface catalog #: ni lot #: ni the product was evaluated through review of manufacturing records, however the reported event could not be confirmed. The device history records were reviewed and no discrepancies were identified. Per the package insert for the gender solutions patello-femoral joint, loosening is one of the adverse effects of total knee arthroplasty. However, a definitive root cause cannot be determined due to insufficient information provided. 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. Multiple mdr reports were filed for this event; please see all reports associated with this event. 0001822565-2017-06372 0001822565-2018-04856
Patient Sequence No: 1, Text Type: N, H10
[132805581]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2017-06372 |
| MDR Report Key | 6864204 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2017-09-14 |
| Date of Report | 2018-09-05 |
| Date of Event | 2011-10-11 |
| Date Mfgr Received | 2018-08-14 |
| Device Manufacturer Date | 2010-01-29 |
| Date Added to Maude | 2017-09-14 |
| 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 | GENDER SOLUTIONS PATELLO-FEMORAL TROCHLEA COMPONENT |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | KRR |
| Date Received | 2017-09-14 |
| Model Number | N/A |
| Catalog Number | 00592601301 |
| Lot Number | 61408743 |
| ID Number | N/A |
| 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. Hospitalization; 2. Required No Informationntervention | 2017-09-14 |