MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN POLYETHYLENE INSERT 6MM IMPLANT

Catalog Number UNK_SEL

Device Problem Fracture (1260)

Patient Problems Cyst(s) (1800); Failure of Implant (1924); Injury (2348)

Event Date 02/01/2000

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), united states. The title of this report is ¿polyethylene fracture following star ankle arthroplasty: a report of three cases¿ which is associated with the stryker ¿scandinavian total ankle replacement (star)¿ system. Within that publication, post-operative complications/ adverse events were reported, which occurred from february 2000 to december 2007. It was not possible to ascertain specific device 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 5 complaints were initiated retrospectively for adverse events mentioned in the report. This product inquiry addresses polyethylene insert fracture and cystic lesions followed by revision and bone graft. The report states: ¿the patient functioned well until november 2007, when he experienced the sudden onset of severe pain unassociated with any traumatic event. On exam, he was able to dorsiflex his ankle 10 degrees and plantarflex 15 degrees, which was slightly decreased from the 10 degrees of dorsiflexion and 30 degrees of plantarflexion measured at 12-months postoperatively, and the ankle exhibited a valgus malalignment. Plain radiographs revealed a fractured polyethylene insert in addition to both tibial and talar cystic lesions [. ]. A computed tomography scan was then obtained to evaluate the size of these lesions, and showed good bony support of the talar prosthesis, as well as thick pillars of bone supporting the barrels of the tibial component [. ]. In december 2007, the patient underwent removal of the fractured polyethylene insert with retention of the well-fixed tibial and talar components [. ]. The tibial and talar cysts were bone grafted and a new 7-mm polyethylene meniscus was implanted. ".

• Brand Name: UNKNOWN POLYETHYLENE INSERT 6MM
• 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: 9902960
• MDR Text Key: 192026658
• Report Number: 0008031020-2020-00889
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/04/2020
• 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 Treatment Data

Date Received: 03/31/2020 Patient Sequence Number: 1