MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2017-09-14 for GENDER SOLUTIONS PATELLO-FEMORAL TROCHLEA COMPONENT N/A 00592601202 manufactured by Zimmer Biomet, Inc..
[86085425]
(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
[86085426]
It was reported that patient underwent a total knee replacements and subsequently the left knee was revised due to loosening.
Patient Sequence No: 1, Text Type: D, B5
[133222129]
This follow-up report is being submitted to relay corrected and additional information. Updated: corrected: reported event was unable to be confirmed due to limited information received from the customer. Dhr was reviewed and no discrepancies were found. In the package insert, loosening or fracture/damage of the prosthetic knee components is listed as possible adverse effects. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.
Patient Sequence No: 1, Text Type: N, H10
[133222130]
It was reported that patient underwent bilateral patella femoral replacements, and subsequently the right knee was revised due to loosening.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2017-06373 |
| MDR Report Key | 6864203 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-09-14 |
| Date of Report | 2018-05-11 |
| Date of Event | 2012-04-24 |
| Date Mfgr Received | 2018-05-10 |
| Device Manufacturer Date | 2009-02-23 |
| 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 | 00592601202 |
| Lot Number | 61183519 |
| ID Number | N/A |
| Device Expiration Date | 2019-01-31 |
| 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 |