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 2020-03-26 for UNKNOWN LONGEVITY POLYETHYLENE LINER N/A manufactured by Zimmer Biomet, Inc..
[185975066]
(b)(4). Concomitant medical products: unk-unk m/l taper size 15 stem-unk, unk-36mm+0 cocr head-unk, unk-unknown cup-unk. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 01079, 0001822565 - 2020 - 01080, 0001822565 - 2020 - 01082. Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Device remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[185975068]
It was reported the patient is experiencing signs of elevated cobalt levels, cardiac issues, problems with balance, sleep disorder worsened, and constant coldness/numbness in feet, hands along with decline in ability to hear approximately 5 years post implantation. These issues have remained up to 7 years post implantation. No report of revision at this time. Attempts have been made and additional information on the reported event is unavailable at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2020-01081 |
| MDR Report Key | 9882693 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-03-26 |
| Date of Report | 2020-04-02 |
| Date Mfgr Received | 2020-03-31 |
| Date Added to Maude | 2020-03-26 |
| 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 | NI |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN LONGEVITY POLYETHYLENE LINER |
| Generic Name | PROSTHESIS, HIP |
| Product Code | KWY |
| Date Received | 2020-03-26 |
| Model Number | N/A |
| Catalog Number | NI |
| Lot Number | NI |
| 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 | 0 | 1. Other | 2020-03-26 |