MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SERIES I TIBIAL BEARING INSERT; IMPLANT

Catalog Number 3051-0508

Device Problems Degraded (1153); Device Slipped (1584); Material Integrity Problem (2978); Naturally Worn (2988)

Patient Problems Tissue Damage (2104); Injury (2348); No Code Available (3191)

Event Date 05/14/2014

Event Type  Injury  

Event Description

It was reported that the insert which was implanted for left knee and replaced 12 years after implanted.The implant was implanted in (b)(6) 1993.Soft tissue loosening was confirmed, so it (8mm) was changed to 15mm insert.

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

An event regarding joint instability involving a scorpio insert was reported.The event was confirmed.Method & results: -device evaluation and results: a visual inspection found no material or manufacturing defects.A visual inspection showed evidence of delamination and pitting.These are fatigue wear mechanisms are consistent with commonly identified damage modes in uhmwpe inserts.-medical records received and evaluation: not performed as no patient information was provided for review.-device history review: all devices accepted into final stock conformed to specification.-complaint history review: there have been no similar previous reported events for this lot id.Conclusions: the exact cause of the event could not be determined because insufficient patient medical records were provided for review.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.

Event Description

It was reported that the insert which was implanted for left knee and replaced 12 years after implanted.The implant was implanted in (b)(6)1993.Soft tissue loosening was confirmed, so it (8mm) was changed to 15mm insert.

• Brand Name: SERIES I TIBIAL BEARING INSERT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3910771
• MDR Text Key: 4488860
• Report Number: 0002249697-2014-02527
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K862837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: 3051-0508
• Device Lot Number: AYBF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2011
• 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): Hospitalization; Required Intervention