MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-27 for RESTORATION ADM X3 INS 28/48 1236-2-848 manufactured by Stryker Orthopaedics-mahwah.
[188806736]
An event regarding disassociation involving an adm liner was reported. The event was confirmed via clinician review. Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned. Medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: no examination of the explanted components and no spinal x-rays to demonstrate deformity or the extent of the fusion are available. As a result of fixed spinal deformity, acetabular component placement may be malpositioned resulting in repeated impingement resulting in trauma to the mdm bearing and ultimate dislocation. Examination of the patient? S spine and the explanted components could confirm this mechanism and rule out factors of implant manufacturing or materials as having contributed to this clinical situation. Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies. Complaint history review: there have been 3 other similar events for the lot referenced. Conclusions: the medical review revealed that as a result of fixed spinal deformity, acetabular component placement may be malpositioned resulting in repeated impingement resulting in trauma to the mdm bearing and ultimate dislocation. Examination of the patient? S spine and the explanted components could confirm this mechanism and rule out factors of implant manufacturing or materials as having contributed to this clinical situation. The exact cause of the event could not be determined because insufficient information was provided. Further information such as examination of the explanted components and spinal x-rays to demonstrate deformity or the extent of the fusion are needed to complete the investigation for determining root cause. No further investigation for this event is possible at this time. 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
[188806737]
January 31, 2020 update via med review: the polyethylene had disassociated from the femoral head. This pi is for revision surgery done on (b)(6) 2018. Patient called stating he had a left hip replacement done on (b)(6) 2014. Patient had 3 dislocations with 3 manipulations in a short period of time. Revision surgery took place 2 weeks later. Update 16-jan-2020: medical records were received, it was noted that the patient had a left hip replacement done on (b)(6) 2014 not (b)(6) 2014. The patient had 1 closed reduction on (b)(6) 2018 and a second closed reduction on (b)(6) 2018. Following this the patient had a revision surgery on (b)(6) 2018. Removal and exchange of liner.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2020-00413 |
| MDR Report Key | 9765472 |
| Report Source | CONSUMER |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-27 |
| Date of Event | 2014-12-01 |
| Date Mfgr Received | 2020-01-31 |
| Device Manufacturer Date | 2014-01-09 |
| Date Added to Maude | 2020-02-27 |
| 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 | 2020-02-27 |
| Model Number | 1236-2-848 |
| Catalog Number | 1236-2-848 |
| Lot Number | 46482101 |
| Device Expiration Date | 2019-01-31 |
| 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 | 2020-02-27 |