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); Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 03/26/2018

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It was reported that patient's ankle (side not reported) was revised due to the surgeon's suspicion of implant loosening.Intra-operatively, the poly was found to have been broken.

Manufacturer Narrative

The reported event of broken sliding core after approx.15 years was confirmed on provided images.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.Patient data and medical records were not provided.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.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

It was reported that patient's ankle (side not reported) was revised due to the surgeon's suspicion of implant loosening.Intra-operatively, the poly was found to have been broken.

• 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
• MDR Report Key: 7504822
• MDR Text Key: 107959178
• Report Number: 0008031020-2018-00357
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• PMA/PMN Number: P050050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Date Manufacturer Received: 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention