MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN STAR ANKLE; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME

Catalog Number UNK_SEL

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 04/08/2010

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device disposition is unknown.

Event Description

The manufacturer became aware of an implant summary report from (b)(6).This national joint registry was produced on 13 july 2018 and is associated with ¿star ankle¿.Within that publication, post-operative complications/ adverse events were reported, which occurred between april 2010 and may 2018.It was not possible to ascertain specific device or patient information from the report, a review of the complaint handling database, however, revealed that the events have not been reported previously, therefore 22 complaints were initiated retrospectively for different adverse events mentioned in the study.This product inquiry addresses talar aseptic loosening.

• Brand Name: UNKNOWN STAR ANKLE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
• 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: 8042504
• MDR Text Key: 126353298
• Report Number: 0008031020-2018-00947
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• 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
• Date Manufacturer Received: 10/11/2018
• 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): Other