MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CONSTRAINED ACETABULAR INSERTS; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number 2099-2250

Device Problems Material Deformation (2976); Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 03/03/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Patient recieved a left hip revision surgery due to instability & failed hardware.

Manufacturer Narrative

An event regarding instability & failed hardware was reported.An event for wear and locking ring dissociation was confirmed.Method & results: -device evaluation and results: could not be performed as no items associated with the event were returned or made available for evaluation.-medical records received and evaluation: a review of the provided medical records concluded: no evidence is available to suggest that device-related factors might have played a role while the present failure scenario as based upon procedure-related factors provides a plausible explanation for the failure event of this case consistent with all facts and findings.This pi case is not device-related.Cup shell malposition in low inclination and low anteversion, caused impingement between stem neck and outer bearing but because the femoral head was prevented from dislocation by the constrained system, polyethylene wear with rim damage developed causing progressive eccentricity of the femoral head in the cup system until clinical symptoms developed" conclusions: a medical review concluded: "cup shell malposition in low inclination and low anteversion, caused impingement between stem neck and outer bearing but because the femoral head was prevented from dislocation by the constrained system, polyethylene wear with rim damage developed causing progressive eccentricity of the femoral head in the cup system until clinical symptoms developed".There was no indication of a device related issue based on review of the medical review.No further investigation is required at this time.Additional information, including lot details and device return are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

Patient received a left hip revision surgery due to instability & failed hardware.

• Brand Name: CONSTRAINED ACETABULAR INSERTS
• Type of Device: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• 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 colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6447459
• MDR Text Key: 71322871
• Report Number: 0002249697-2017-01089
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960047
• 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: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2099-2250
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 75 YR
• Patient Weight: 108