MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN REMOTION WRIST LEFT RADIAL IMPLANT MEDIUM

Catalog Number UNK_SEL

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

Patient Problems Nerve Damage (1979); Pain (1994)

Event Date 06/05/2020

Event Type  Injury  

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.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.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.Device disposition is unknown.

Event Description

The manufacturer became aware of a post market clinical follow-up report received from (b)(6) hospital, in usa.The title of this report is ¿a retrospective data collection of the replacement of the total wrist joint due to rheumatoid arthritis, osteo-arthritis or post-traumatic arthritis with remotion total wrist system¿ which is associated with the stryker ¿remotion total wrist¿ system.The treatment period of patients included in this report was between january 1, 2014 and december 31, 2019.It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints.Therefore 7 complaints were initiated retrospectively for the post-operative complications mentioned in the report.This product inquiry addresses pain throughout the hand at night and nerve sensitivity at 6 months follow up.

• Brand Name: UNKNOWN REMOTION WRIST LEFT RADIAL IMPLANT MEDIUM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10237402
• MDR Text Key: 199935296
• Report Number: 0008031020-2020-01848
• Device Sequence Number: 1
• Product Code: JWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• 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: 06/10/2020
• 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): Other
• Patient Age: 73 YR
• Patient Weight: 90