MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-02-25 for TM REVERSE BASE PLATE N/A 00434903811 manufactured by Zimmer Biomet, Inc..
[187393757]
(b)(4). X-rays were provided, but were found to be non-relevant to the reported event. Medical records were not provided for review. It was reported however, that the surgeon believes the reason for device failure was due to medical issues with the patient. The patient has some problems with her lower extremities and is reliant on her upper extremities to assist in standing from a sitting position. The reported event cannot be confirmed from this information. Review of the device history records identified no deviations or anomalies during manufacturing. A definitive root cause cannot be determined. 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. Event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[187393758]
It was reported that approximately 2. 5 years post implantation, the patient was revised due to device migration. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2020-00701 |
| MDR Report Key | 9750519 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-25 |
| Date of Event | 2018-07-03 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2015-08-03 |
| Date Added to Maude | 2020-02-25 |
| 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 REVERSE BASE PLATE |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | KWT |
| Date Received | 2020-02-25 |
| Model Number | N/A |
| Catalog Number | 00434903811 |
| Lot Number | 63122393 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-02-25 |