MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2020-03-30 for UNKNOWN HEAD N/A manufactured by Zimmer Biomet, Inc..
[185611089]
(b)(4). Item #: unknown , unknown stem, lot #: unknown. Item #: unknown , unknown liner, lot #: unknown. Item #: unknown, unknown cup, lot #: unknown. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-01111. Reported event was confirmed by maude report. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. 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
[185611090]
It was reported that a patient underwent a primary tha approximately nine years ago. Currently, the patient is experiencing pain, memory issues, tremors, neuropathy, and elevated metals ions. The patient subsequently underwent a revision of the femoral head. In addition, approximately three months post revision, the patient has exhibited a decrease in the elevated ion levels. Attempts have been made for additional information, however, at the time of this report, no further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2020-01108 |
| MDR Report Key | 9900360 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2009-11-17 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-30 |
| 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 | UNKNOWN HEAD |
| Generic Name | PROSTHESIS, HIP |
| Product Code | LPH |
| Date Received | 2020-03-30 |
| Model Number | N/A |
| Catalog Number | NI |
| Lot Number | NI |
| 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 | 2020-03-30 |