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

Catalog Number UNK_SEL

Device Problems Loss of Osseointegration (2408); Naturally Worn (2988)

Patient Problem Inadequate Osseointegration (2646)

Event Date 11/24/2023

Event Type  Injury  

Event Description

The manufacturer became aware of a published article titled ¿long-term results and explant analysis of the remotion total wrist arthroplasty¿.Allegedly, the author indicated that (1) patient experienced late aseptic loosening that were successfully revised to motec twas 11 years postoperatively.The report states ¿the two implants revised for aseptic loosening are shown.Neither specimen showed major or catastrophic wear; however, both explants showed multidirectional scratches on the articulating surface of the radial plate and concentric scratches on the carpal plate.There were also concentric scratches observed on the backside of the polyethylene insert¿.

Manufacturer Narrative

This complaint has been generated based on findings discovered during the post-market surveillance literature review.The alleged event of ¿revision surgery¿ could not be confirmed, since no additional information was received from the author or the article.More detailed information about the patient medical history, the event circumstances, and medical reports must be available to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.H3 other text : device disposition is unknown.

• Brand Name: UNKNOWN REMOTION WRIST RADIAL PLATE
• 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: 18704833
• MDR Text Key: 335371965
• Report Number: 0008031020-2024-00094
• Device Sequence Number: 1
• Product Code: JWJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• 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: 01/18/2024
• 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