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 2020-03-07 for RESTORATION ADM X3 INS 28/48 1236-2-848 manufactured by Stryker Orthopaedics-mahwah.
[188806453]
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies. There have been no other similar events for the lot referenced. It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[188806454]
It was reported through the submission of a usage sheet that the patient's left hip was revised. In comparing the revision usage sheet with a previous revision usage sheet, a 28 +0 biolox head and 42e adm/ mdm insert were revised to a 28 +4 biolox head and another 42e adm/mdm insert. Update: "the patient was revised to a 28 +4 lfit head and the same 42 e liner she had in before. Reason for the revision was an inter-prosthetic dislocation. The 28 +0 biolox head that was originally implanted became disassociated from the mdm insert. There was no noticeable wear or damage to the mdm insert. The in/out implants were because the doctor decided to change the femoral head size to add more stability. He elected not to trial at first but then wanted to change the length. No explanted products are available for return per hospital policy. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2020-00477 |
| MDR Report Key | 9803599 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-03-07 |
| Date of Report | 2020-03-07 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2019-01-27 |
| Date Added to Maude | 2020-03-07 |
| 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 | MR. COLLIN NEITZEL |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS-CORK |
| Manufacturer Street | IDA INDUSTRIAL ESTATE |
| Manufacturer City | CARRIGTWOHILL NA |
| Manufacturer Country | IE |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESTORATION ADM X3 INS 28/48 |
| Generic Name | PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU |
| Product Code | MEH |
| Date Received | 2020-03-07 |
| Model Number | 1236-2-848 |
| Catalog Number | 1236-2-848 |
| Lot Number | 70046901 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOPAEDICS-MAHWAH |
| Manufacturer Address | 325 CORPORATE DRIVE MAHWAH NJ 07430 US 07430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-07 |