MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN STAR TALAR COMPONENT; IMPLANT

Catalog Number UNK_SEL

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Debris, Bone Shedding (1803); Injury (2348)

Event Date 01/01/1993

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 (b)(6) hospital, (b)(6).The title of this report is 'survival analysis of the single- and double-coated star ankle up to 20 years: long-term follow-up of 324 cases from the swedish ankle registry' which is associated with the stryker star prosthesis.Within that publication, postoperative complications/ adverse events were reported which occurred between 1993 and 2007.It was not possible to ascertain specific device or patient details from the study, 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 147 complaints was initiated retrospectively for adverse event mentioned in the study.This product inquiry addresses debridement of the gutters and stabilization of the ankle by ligament augmentation.5 out of 22 cases.The study states: "11 secondary surgical procedures were performed in each design group, the most common being debridement of the gutters and stabilization of the ankle by ligament augmentation and/or different osteotomies.".

Manufacturer Narrative

New information in section h6 (patient code) & correction in section h6 (device code).

Event Description

The manufacturer became aware of a study from (b)(6) hospital, sweden.The title of this report is 'survival analysis of the single- and double-coated star ankle up to 20 years: long-term follow-up of 324 cases from the swedish ankle registry' which is associated with the stryker star prosthesis.Within that publication, postoperative complications/ adverse events were reported which occurred between 1993 and 2007.It was not possible to ascertain specific device or patient details from the study, 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 147 complaints was initiated retrospectively for adverse event mentioned in the study.This product inquiry addresses debridement of the gutters and stabilization of the ankle by ligament augmentation.5 out of 22 cases.The study states: "11 secondary surgical procedures were performed in each design group, the most common being debridement of the gutters and stabilization of the ankle by ligament augmentation and/or different osteotomies.".

• Brand Name: UNKNOWN STAR TALAR COMPONENT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9526289
• MDR Text Key: 185670902
• Report Number: 0008031020-2019-02422
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• 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: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention