MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN TIBIAL COMPONENT; IMPLANT

Catalog Number UNK_SEL

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Bone Fracture(s) (1870); Injury (2348)

Event Date 03/01/1999

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.The reported device was manufactured and distributed by small bone innovation, inc., (b)(4) and implanted before stryker became the legal manufacturer.On april 1, 2015 stryker became the legal manufacturer of the star system and has taken the responsibility for the medical device reporting.Device disposition is unknown.

Event Description

The manufacturer became aware of a literature from (b)(6).The title of this report is ¿total ankle replacement in 35 cases¿ which is associated with the stryker ¿star¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from march 1999 to november 2006.It was not possible to ascertain specific device/patient 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 10 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses medial malleolus fracture.2 out of 2 cases.The report states: ¿during the surgery, medial malleolus fracture occurred in 2 patients, because of faults in osteotomy and an insertion of excessively wide semilunar liner, respectively.However, this complication did not influence prosthetic stability subsequent to fixation of absorbable screws.¿.

• Brand Name: UNKNOWN TIBIAL COMPONENT
• 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: 9832404
• MDR Text Key: 191826410
• Report Number: 0008031020-2020-00694
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• 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: 02/17/2020
• 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