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

Catalog Number UNK_SEL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 05/01/2014

Event Type  Injury  

Manufacturer Narrative

With guidance from the mdr policy branch of the fda, mdr reported by stryker (b)(4) as a result of a retrospective lookback of complaints resulting from the acquisition of assets from small bone innovation, inc.The reported device was manufactured and distributed by small bone innovation, inc., (b)(4) and implanted prior to howmedica osteonics corp.¿s purchase of certain assets of sbi on august 1, 2014.Stryker became legal manufacturer of this product on april 1, 2015 and has taken the responsibility for medical device reporting.Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device evaluated by mfr: device disposition unknown.

Event Description

The manufacturer became aware of a study from department of trauma & orthopaedics, altnagelvin hospital, northern ireland, uk.The title of this study is ¿pre-requisites for optimum centering of a tibiotalocalcaneal arthrodesis nail¿ and is associated with the t2 ankle arthrodesis nail.The study published in may 2014 reported post-operative complications/ adverse events.It was not possible to ascertain specific device catalogs 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, 9 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses chronic discharging sinus.The study states: ¿chronic discharging sinus in the patient who underwent ttc for a failed total ankle replacement was due to residual debris within the soft tissues from wear of the poly and resolved with exploration and wound debridement at eleven months post nailing.[¿] soft tissue related complications in 6 cases resolved with simple measures, except in a rheumatoid patient who required re-exploration and debridement for chronic discharging sinus secondary to poly reaction following conversion to ttc for failed total ankle replacement.¿.

• Brand Name: UNKNOWN STAR MOBILE BEARING
• 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8524315
• MDR Text Key: 142334128
• Report Number: 0008031020-2019-00359
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: P050050
• 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: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2019
• 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