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 2018-02-02 for BONE SCR 6.5X30 SELF-TAP N/A 00625006530 manufactured by Zimmer Biomet, Inc..
[98834301]
(b)(4). Concomitant medical products: 00620006022, trilogy cup, 61260637, 00631006036, xlpe liner 10 degree elevated rim 3. 5 mm offset 36 mm, 61227274, 00801803605, cocr femoral head, 60810391. Report source, foreign? Events occurred in (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 00644, 0001822565 - 2018 - 00646, 0001822565 - 2018 - 00647.
Patient Sequence No: 1, Text Type: N, H10
[98834302]
It was reported that a patient underwent a left hip procedure. Subsequently, infection was reported approximately four days after implantation. Attempts have been made and additional information on the reported event is unavailable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2018-00645 |
| MDR Report Key | 7235769 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-02-02 |
| Date of Report | 2018-04-19 |
| Date of Event | 2009-12-06 |
| Date Mfgr Received | 2018-04-18 |
| Device Manufacturer Date | 2009-02-02 |
| Date Added to Maude | 2018-02-02 |
| 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 | BONE SCR 6.5X30 SELF-TAP |
| Generic Name | PROSTHESIS, HIP |
| Product Code | NLF |
| Date Received | 2018-02-02 |
| Model Number | N/A |
| Catalog Number | 00625006530 |
| Lot Number | 61185899 |
| 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. Other | 2018-02-02 |