MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SERIES I TIBIAL BEARING INSERT; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 3051-0508

Device Problems Degraded (1153); Material Integrity Problem (2978); Naturally Worn (2988)

Patient Problems Pain (1994); Injury (2348)

Event Date 05/24/2016

Event Type  Injury  

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Event Description

Primary tka was performed on (b)(6) 1996.This time, the revision surgery due to the pain and squeaking was performed on (b)(6) 2016.The insert was exchanged because it was wearing.The surgeon has requested the wear investigation of the insert.

Manufacturer Narrative

An event regarding wear involving an scorpio insert was reported.The event was confirmed.Method and results: device evaluation and results: based on received mar it is concluded damage was observed on the anterior surface of the insert, consistent with explantation damage and wear was seen on the inferior surface.No material or manufacturing defects were observed on the surfaces examined.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there has been no other event for the lot referenced.Conclusions: based on the mar, it is concluded that red outlines indicate damage was observed on the anterior surface that are consistent with explantation damage and wear was seen on the inferior surface.No material or manufacturing defects were observed on the surfaces examined.No further investigation for this event is possible at this time.If additional information become available, this investigation will be reopened.

Event Description

Primary tka was performed on (b)(6) 1996.This time, the revision surgery due to the pain and squeaking was performed on (b)(6) 2016.The insert was exchanged because it was wearing.The surgeon has requested the wear investigation of the insert.

• Brand Name: SERIES I TIBIAL BEARING INSERT
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5739626
• MDR Text Key: 47867775
• Report Number: 0002249697-2016-01996
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K862837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2001
• Device Catalogue Number: 3051-0508
• Device Lot Number: 22201802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/1996
• 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