MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2020-02-21 for RESTORATION ADM X3 INS 28/48 1236-2-848 manufactured by Stryker Orthopaedics-mahwah.
[184897922]
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. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[184897923]
Patient had a cup revision and an mdm was implanted on the (b)(6) 2020. Then on the (b)(6) the patient dislocated their hip and the adm x3 liner disassociated from the femoral head. Patient has history of reoccurring dislocations and unusual anatomy as noted by surgeon. Both x3 and femoral head component did not appear damaged. Patient also had +8mm femoral head implanted and surgeon felt skirt on this may have lead to dislocation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2020-00371 |
| MDR Report Key | 9739525 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-01-26 |
| Date Mfgr Received | 2020-01-26 |
| Device Manufacturer Date | 2019-05-21 |
| Date Added to Maude | 2020-02-21 |
| 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 | 2020-02-21 |
| Model Number | 1236-2-848 |
| Catalog Number | 1236-2-848 |
| Lot Number | 72269501 |
| 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 | 2020-02-21 |