MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN REMOTION WRIST CARPAL SCREW IMPLANT

Catalog Number UNK_SEL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 01/01/2009

Event Type  Injury  

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the labeling did not indicate any abnormalities.As per ifu: contraindications: bone, musculature, tendons, or adjacent soft tissue compromised by disease, infection, or prior implantation, which cannot provide adequate support or fixation for the prosthesis.Known sensitivity to materials used in this device.Strenuous loading, excessive mobility, and articular instability all may lead to accelerated wear and eventual failure by loosening, fracture, or dislocation of the device.Patients should be made aware of the increased potential for device failure when excessive demands are made upon it.Reuse of instruments designated as single use has been associated with necrosis of bone leading to implant failure.Also, as per ifu some of the adverse events are: there have been some reports of patients with metal sensitivity reactions following joint replacement.Implantation of materials such as cobalt chrome and/or titanium may result in foreign body reaction adjacent to the implant site.Injury to the surrounding nerves, blood vessels, tendons, or soft tissues can occur as a consequence of implanting this device.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device evaluated by mfr: device disposition unknown.

Event Description

The manufacturer became aware of a study from (b)(6) hospital (b)(6).The title of this study is ¿what we know after a decade of total wrist prostheses¿ and is associated with the remotion total wrist system.Within that publication, post-operative complications/ adverse events were reported, which occurred between 2009 and 2015.It was not possible to ascertain specific device catalogs from the report; a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication.Therefore, 30 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses lysis.11 out of 22 cases.

• Brand Name: UNKNOWN REMOTION WRIST CARPAL SCREW IMPLANT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: kevin smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8727024
• MDR Text Key: 149067205
• Report Number: 0008031020-2019-00704
• Device Sequence Number: 1
• Product Code: JWJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention