MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2018-10-08 for NEUTRAL LINER 32 MM I.D. SIZE II FOR USE WITH 52 MM O.D. SIZE II SHELL N/A 00885101032 manufactured by Zimmer Biomet, Inc..
[123057688]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown. Concomitant medical products: item number: 00875705201, item name: shell with cluster holes porous 52 mm o. D. Size ii for use with ii liners, lot #: 62939160, item number: 00877503202, item name: biolox® delta, ceramic femoral head, m, ø 32/0, taper 12/14, lot #: 2772592, item number: 0106010106, item name: avenir® müller, stem, lateral, uncemented, ha, 6, taper 12/14, lot #: 4023582. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 05553. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[123057689]
It was reported patient is experiencing pain approximately 3 years post-implantation. Attempts have been made and no additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2018-05554 |
| MDR Report Key | 7944946 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2018-10-08 |
| Date of Report | 2019-02-21 |
| Date Mfgr Received | 2019-02-18 |
| Device Manufacturer Date | 2014-07-09 |
| Date Added to Maude | 2018-10-08 |
| 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 | NEUTRAL LINER 32 MM I.D. SIZE II FOR USE WITH 52 MM O.D. SIZE II SHELL |
| Generic Name | PROSTHESIS, HIP |
| Product Code | OQI |
| Date Received | 2018-10-08 |
| Model Number | N/A |
| Catalog Number | 00885101032 |
| Lot Number | 62720420 |
| Device Expiration Date | 2019-05-31 |
| 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 | 2018-10-08 |