MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN REMOTION IMPLANT; PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED

Catalog Number UNK_SEL

Device Problems Break (1069); Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 07/07/2017

Event Type  Injury  

Event Description

The manufacturer became aware of a literature published by the ¿department of orthopedic surgery, division of hand surgery, mayo clinic, usa¿.The title of this report is ¿what are the risk factors and complications associated with intraoperative and postoperative fractures in total wrist arthroplasty?¿, published on july 07, 2017, and can be found at doi 10.1007/s11999-017-5442-2.The report is associated with the stryker ¿remotion total wrist system¿ and includes an analysis of the clinical data that was collected on 425 patients.During the review of the literature, it was not possible to establish a precise device(s) identification or patient information; however, the article alleges that 1 patient experienced a postoperative fracture of the metacarpal, and distal loosening which required immobilization and revision total wrist arthroplasty.

Manufacturer Narrative

This complaint has been generated based on findings identified during post market surveillance literature review published by the ¿department of orthopedic surgery, division of hand surgery, mayo clinic, usa¿.The article can be found at https://doi.Org/10.1007/s11999-017-5442-2.The reported event could not be confirmed since the device was not returned for evaluation and no other additional information was received from the author.More detailed information about the patient's medical history, the event details and the involved device(s) must be available to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.Device disposition unknown.

• Brand Name: UNKNOWN REMOTION IMPLANT
• Type of Device: PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15491474
• MDR Text Key: 300646451
• Report Number: 0008031020-2022-00478
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 09/01/2022
• 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