MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SYMAX HIP STEM SIZE 5 LEFT; HIP IMPLANT

Catalog Number 1131-0510

Device Problems Device Slipped (1584); Unstable (1667); Noise, Audible (3273)

Patient Problem Pain (1994)

Event Date 11/12/2015

Event Type  Injury  

Manufacturer Narrative

The subject device is not cleared for sale in the u.S., but a similar device is commercially available in the u.S.

Event Description

The patient visited the hospital in (b)(6) with pain and in stability in the hip.The (b)(6) 2015, xray was taken and the head was loose from the stem.The patient had also been at (b)(6) hospital (b)(6) 2015 due to a clicking sound in the hip xray was taken.No action was taken.

Manufacturer Narrative

An event regarding instability involving a symex stem was reported.The event was confirmed for disassociation following review by a medical professional and following material analysis.Method and results: a visual inspection was performed as part of the material analysis report.Damage was observed on the trunnion of the hip stem.The damage observed was likely due to the hip stem trunnion dissociating from the v40 head taper, allowing the stem trunnion to articulate against the trident insert.The material analysis report concluded that: damage was observed on the insert, hip stem trunnion and v40 head taper.The damage observed was likely due to the hip stem trunnion dissociating from the v40 head taper, allowing the stem trunnion to articulate against the trident insert.Wear analysis could not be performed on the insert due to the damage observed.Black debris was observed on the v40 head.Eds was performed on the hip stem, v40 head and black debris.The hip stem was consistent with ti-6al-4v eli alloy.The v40 head was consistent with a cocr alloy.The black debris was consistent with biological material, a corrosion product from the v40 head, and the hip stem.No materials or manufacturing defects were observed on the surfaces examined.A review of the medical records by a clinical consultant could confirm the event but could not determine a root cause.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.However no material or manufacturing defects were observed on the returned devices.Further information such as operative reports, additional xrays, patient history and follow-up notes are needed to investigate this event further.If additional information becomes available, this investigation will be reopened.

Event Description

The patient visited the hospital in (b)(6) with pain and in stability in the hip the (b)(6) 2015, x-ray was taken and the head was loose from the stem.The patient had also been at (b)(6) hospital (b)(6) 2015 due to a clicking sound in the hip x-ray was taken.No action was taken.

• Brand Name: SYMAX HIP STEM SIZE 5 LEFT
• Type of Device: HIP IMPLANT
• 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 navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5419121
• MDR Text Key: 37778701
• Report Number: 0002249697-2016-00371
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: SE
• 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: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2012
• Device Catalogue Number: 1131-0510
• Device Lot Number: 22833501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2007
• 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: 59 YR
• Patient Weight: 102