MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN RADIAL HEAD; IMPLANT

Catalog Number UNK_SEL

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Weakness (2145)

Event Date 01/01/2009

Event Type  Injury  

Manufacturer Narrative

This complaint has been reported during a literature review performed by the post market surveillance group.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 study from ¿(b)(6).The title of this report is ¿radial head replacement with unipolar and bipolar sbi system: a clinical and radiographic analysis after a 2-year mean follow-up¿ which is associated with the stryker rhead system.Within that publication, post-operative complications/adverse events were reported which occurred between january 2009 and december 2010.It was not possible to ascertain specific device details 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 22 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses prosthesis removal due to aseptic loosening.The study states, ¿the first case is the woman (patient nr.9) with a circumferential bone resorption greater than 7 mm., who underwent the prosthesis removal at 20 months, because of aseptic loosening.Eight months after the removal the patient had a complete recovery of flexion, extension, pronation, and supination and a completely stable elbow, with the persistence of a slight forearm weakness.¿.

• Brand Name: UNKNOWN RADIAL HEAD
• 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: 9319059
• MDR Text Key: 184994516
• Report Number: 0008031020-2019-01647
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• 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: 10/17/2019
• 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
• Patient Age: 56 YR