MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MODULAR DUAL MOBILITY INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 626-00-38D

Device Problems Material Separation (1562); Insufficient Information (3190)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 12/18/2014

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information was requested and if it becomes available, the evaluation summary will be submitted in a supplemental report.Hospital policy.

Event Description

It was reported that patient was revised on a right hip due to disassociation of mdm insert.

Manufacturer Narrative

An event regarding disassociation involving an mdm liner was reported.The event was not confirmed.Method and results: device evaluation and results: not performed as the reported device was not returned for evaluation.Medical records received and evaluation: a medical review was not performed because insufficient information was provided.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes, x-rays and return of the device 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

It was reported that patient was revised on a right hip due to disassociation of mdm insert.

Manufacturer Narrative

An event regarding disassociation involving an mdm liner was reported.The event was not confirmed.Method & results: -device evaluation and results: damage was noted around the locking mechanism of the liner most likely due usage.A dimensional inspection could not be performed due to the damages described in the visual inspection.A functional inspection was not performed as the event cannot be replicated.-medical records received and evaluation: a medical review was not performed because insufficient information was provided.-device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: review indicated 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.Additional information, including operative reports, progress notes, x-rays and return of the device 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

It was reported that patient was revised on a right hip due to disassociation of mdm insert.

• Brand Name: MODULAR DUAL MOBILITY INSERT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: 4420400
• MDR Text Key: 19047210
• Report Number: 0002249697-2015-00121
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103233
• 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,Followup,Followup
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 626-00-38D
• Device Lot Number: 47987502
• Other Device ID Number: STERILE LOT 1405MCM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2015
• Initial Date FDA Received: 01/15/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/18/2015; 12/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2014
• 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: 63 YR
• Patient Weight: 63