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

Catalog Number UNK_SEL

Device Problems Break (1069); Unintended Movement (3026)

Patient Problem Pain (1994)

Event Date 11/10/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revision due pain, displaced implant and broken poly.

Manufacturer Narrative

The reported event of broken sliding core was confirmed.In the case presented a patient had been treated with a star prosthesis on (b)(6) 2012.After nearly 6 years of implantation the patient experienced pain.Follow-up examination revealed displaced and broken sliding core which was revised with new sliding core was implanted on (b)(6) 2017.The removed sliding core was damaged in such a manner that the lot could no longer be identified.Thus, any manufacturing document could not be reviewed.It could not be determined if the patient¿s weight may have contributed over the years to the event.Operation reports and a few x-rays were made available but did not enable the appointed hcp for a justified assessment.General aspects: the ankle joint with a star implant is a complex mechanisms of motion and is dependent upon proper alignment.A malalignment to this ankle joint complex system affects the interactions between metal and poly and causes degradation of the poly and visual wear on the metal.This is not a design flaw; it is a departure from proper placement of the implant (ref (b)(4), dr.(b)(6)).Review of complaint history, capa databases and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated poly breakage was addressed adequately.There were no actions in place related to the reported event for the subject product.It could not be determined if resp.In what way the patient¿s condition and behaviour may have contributed to the event.Since acknowledgment of the event a repeated request for additional medical records remained without avail.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.If any further information is provided we reserve the rights to update the investigation report.With available information a deficiency of the sliding core was not verified.

Event Description

Revision due pain, displaced implant and broken poly.

• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7076696
• MDR Text Key: 93519927
• Report Number: 0008031020-2017-00683
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 36 YR
• Patient Weight: 129