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

Catalog Number WARRS

Device Problems Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); Arthralgia (2355)

Event Date 08/22/2019

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device was discarded.

Event Description

As reported: "demotion wrist removal patient presented to hospital with regard to knee joint pain, investigation revealed chronic wrist pain and possible infection as reported by plastics department.".

Event Description

As reported: "demotion wrist removal patient presented to hospital with regard to knee joint pain, investigation revealed chronic wrist pain and possible infection as reported by plastics department.".

Manufacturer Narrative

The reported event could not be confirmed.The x-rays sent were reviewed by stryker¿s medical expert, and his clinical opinion about this case is the following: "unfortunately i have received only one image of an ap-view pain of the right hand of the patient.No date of the x-ray is provided.This circumstance affects the quality of the assessment.We see several severe degenerative changes in the bony substance of the wrist, the carpal bones, the metacarpalia as well as the phalanges.All of these changes may contribute to functional impairment and pain in the hand.The demotion wrist implant is also depicted.The radial part of the implant shows no sign of loosening.The carpal part of the implant, however, shows signs of loosening.The optech recommends to resect the lunate, the triquetrum, proximal scaphoid, head of the capitate, and head of the hamate and anchorage in the carpal bone, the scaphoid, the hamatum and the adjacent metacarpals.In the provided x-ray except of a rest of the trapezium and hamatum (both with degenerative structural change making the identification of the bones almost impossible) no further carpal bones can be identified.Additionally, we see a shortened, atrophic rest of the distal ulna.The base of the mc iii and iv show signs of loosening, but this can only be safely assessed with the missing x-ray of this control and the initial x-rays after the insertion of the implant.The x-ray shows destruction and degenerative luxation in several of the surrounding joints: mcp i, mcp ii+iii, pip ii, iii, iv.The loosening of the carpal part of the implant could contribute (or be the main root cause) of the pain (only at the wrist-the other mentioned changes will also cause severe pain in this case and it is questionable whether this can be distinguished by the patient)".Therefore, this event is classified as a mix of a user and environmental related issue.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: WRIST RIGHT RADIAL IMPLANT SMALL
• Type of Device: PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9085069
• MDR Text Key: 162525866
• Report Number: 0008031020-2019-01288
• Device Sequence Number: 1
• Product Code: JWJ
• UDI-Device Identifier: 00886385015583
• UDI-Public: 00886385015583
• Combination Product (y/n): N
• PMA/PMN Number: K021859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: WARRS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR