MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-16 for RESTORATION ADM X3 INS 28/52 1236-2-852 manufactured by Stryker Orthopaedics-mahwah.
[188507312]
An event regarding closed reduction for disassociation involving a adm liner was reported. The event was confirmed by medical review. Method & results: device evaluation and results: not performed as product was not returned. Clinician review: a review of the provided medical records and/or x-rays by a clinical consultant indicated: x-ray printouts available for review include a series dated september 14, 2019, which is an ap of the right hip, demonstrating a hybrid right total hip arthroplasty. The stem and acetabular shell are in nominal position. A small head appears dislocated from the mdm/adm acetabular bearing. The persistent instability of the right total hip arthroplasty since the original surgery for a fractured femoral neck suggests impingement at the extremes of motion and/or malposition of one or both hip components. No imaging studies available, including a lateral, can confirm the version of the components. There is no evidence this clinical situation was related to factors associated with implant design, manufacturing or materials. Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies. Complaint history review: there have been no other similar events for the reported lot. Conclusion: the exact cause of the event could not be determined because insufficient information was provided. Additional information including imaging studies, including a lateral, and return of the device are needed to fully investigate the event. If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Patient Sequence No: 1, Text Type: N, H10
[188507313]
This pi is for the closed reduction of the patient's right hip on (b)(6) 2019. As part of the documents provided for a revision of patient's right hip on (b)(6) 2019, a discharge summary indicates a closed reduction was performed on the patient's right hip for dislocation on (b)(6) 2019. It is not reported which device(s) dislocated or disassociated. Update: as per medical review of x-rays series dated (b)(6) 2019 - "a small head appears dislocated from the mdm/adm acetabular bearing. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2020-00112 |
| MDR Report Key | 9596963 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-16 |
| Date of Report | 2020-01-16 |
| Date of Event | 2019-09-18 |
| Date Mfgr Received | 2019-12-19 |
| Device Manufacturer Date | 2019-04-24 |
| Date Added to Maude | 2020-01-16 |
| 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 Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESTORATION ADM X3 INS 28/52 |
| Generic Name | PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU |
| Product Code | MEH |
| Date Received | 2020-01-16 |
| Catalog Number | 1236-2-852 |
| Lot Number | 71789701 |
| 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. Required No Informationntervention | 2020-01-16 |