MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-08-09 for TM ANKLE TALAR COMPONENT SIZE 4 LEFT N/A 00830001400 manufactured by Zimmer Biomet, Inc..
[116642100]
(b)(4). Date of birth - unknown date, 1953. (b)(6). This device is not distributed in the usa. However, this report is being submitted as zimmer biomet has a similar device in the united states cleared under (b)(4). Multiple mdr's were filed for this event. Please see associated report(s): 0001822565 -2018 -03817. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[116642101]
Patient underwent ankle arthroplasty revision to address progressive valgus malaligment and subsequent instability. No further information has been made available at this time.
Patient Sequence No: 1, Text Type: D, B5
[132200910]
This follow up report is being submitted to relay additional information. Updated: examination of the reported device(s) was not possible as it was not returned. Review of device history records did not identify any related manufacturing deviations or anomalies that would have contributed to the reported event. X-ray review confirms the arthrosis of the ankle joint and tibial loosening. The investigation can draw no further conclusions with the information made available. Root cause is unable to be determined. If any further information is identified 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
[132200911]
No further information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2018-03816 |
| MDR Report Key | 7769500 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-09 |
| Date of Report | 2018-11-30 |
| Date of Event | 2016-10-20 |
| Date Mfgr Received | 2018-11-29 |
| Device Manufacturer Date | 2015-05-18 |
| Date Added to Maude | 2018-08-09 |
| 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 | TM ANKLE TALAR COMPONENT SIZE 4 LEFT |
| Generic Name | PROSTHESIS, EXTREMITY |
| Product Code | ITW |
| Date Received | 2018-08-09 |
| Model Number | N/A |
| Catalog Number | 00830001400 |
| Lot Number | 62990950 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 830005400 | 1. Hospitalization; 2. Required No Informationntervention | 2018-08-09 |