MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-05-05 for NEUTRAL LINER 36 MM N/A 00885101236 manufactured by Zimmer, Inc..
[74583111]
(b)(4). Concomitant medical products: shell with multi holes porous 56 mm o. D. Size kk for use with kk liners, pn 00875705602, ln 62276964; wagner sl revision® hip stem, uncemented, ø 14/190, taper 12/14, pn 0100101914, ln 2685270; biolox® delta, ceramic femoral head, m, ø 36/0, taper 12/14, pn 00877503602, ln 2708230. 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: 0001822565-2017-03001.
Patient Sequence No: 1, Text Type: N, H10
[74583112]
It was reported that patient is experiencing left hip pain and instability one year post implantation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2017-03002 |
| MDR Report Key | 6547681 |
| Report Source | CONSUMER |
| Date Received | 2017-05-05 |
| Date of Report | 2018-01-18 |
| Date Mfgr Received | 2018-01-17 |
| Device Manufacturer Date | 2012-11-01 |
| Date Added to Maude | 2017-05-05 |
| 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, INC. |
| Manufacturer Street | 1800 WEST CENTER STREET |
| Manufacturer City | WARSAW IN 46580 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46580 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUTRAL LINER 36 MM |
| Generic Name | PROSTHESIS, HIP |
| Product Code | OQI |
| Date Received | 2017-05-05 |
| Model Number | N/A |
| Catalog Number | 00885101236 |
| Lot Number | 62192213 |
| ID Number | N/A |
| Device Expiration Date | 2017-10-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | 1800 WEST CENTER STREET WARSAW IN 46580 US 46580 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-05 |