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

Catalog Number UNK_SEL

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

Patient Problems Ossification (1428); Loss of Range of Motion (2032)

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 ¿istituto ortopedico rizzoli, bologna, italy.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 grade 1 periarticular ossifications.4 out of 5 cases.The study states, ¿five patient (16.1 %) developed grade i periarticular ossifications: three of them had a wide recovery of movement (patients nr.3, 10 and 26), the other two (the right elbow of the patient (b)(6) and patient (b)(6)) showed a good recovery of flexion and extension and limitation in pronation and supination.¿.

• Brand Name: UNKNOWN BIPOLAR 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: 9323876
• MDR Text Key: 184938672
• Report Number: 0008031020-2019-01671
• 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: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event 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: 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): Other
• Patient Age: 43 YR