MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN AXSOS 3 5,0MM PLATE; IMPLANT

Catalog Number UNK_SEL

Device Problem Bent (1059)

Patient Problem Failure of Implant (1924)

Event Date 01/17/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

In a periprosthetic treatment of the distal femur, an axsos 3 5.0mm plate was used.The patient was then moved to hoyerswerda at his own request and there it was noticed, that the plate was bent by 30 degrees valgus.The patient was then transferred to the university of dresden where he was operated by professor with the new va lcp from synthes.

• Brand Name: UNKNOWN AXSOS 3 5,0MM PLATE
• 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: 7206034
• MDR Text Key: 97766142
• Report Number: 0008031020-2018-00050
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• 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: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/17/2018
• Initial Date FDA Received: 01/19/2018
• 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