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

Catalog Number UNK_SEL

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

Patient Problem Unspecified Infection (1930)

Event Date 07/15/2010

Event Type  Injury  

Manufacturer Narrative

The reported event that unknown_(b)(4)_product (as reported: unknown star ankle) was alleged of issue (infection) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible and no additional information will be requested to the customer as this serves for trending purpose.Based on the above observations a relationship between the subject implants and the reported infection can be excluded; there is no assumption that the reported stryker implants have caused the infection.Please note that the labeling reviewed in this section is the current version may differ a bit from the one available at the time of the surgery.A review of the labeling did not indicate any abnormalities.If any further information is provided, the investigation report will be updated.Device disposition is unknown.

Event Description

The manufacturer became aware of an implant summary report from (b)(6) and (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 july 2010 and december 2017.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 1 complaint was initiated retrospectively for the adverse event mentioned in the report.This product inquiry addresses infection.

• 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: 8039725
• MDR Text Key: 126215453
• Report Number: 0008031020-2018-00943
• 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: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2018
• 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