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

Catalog Number 626-00-46F

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

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

Event Date 08/02/2016

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

As per sales rep, mdm liner was implanted and was revised next day due to post-op x-ray image that showed liner was not engaged.

Manufacturer Narrative

An event regarding seating/locking issues involving an mdm liner was reported.A clinical review confirmed the event.Method & results: -device evaluation and results: visual inspection:the mdm liner was visually unremarkable.Dimensional inspection: the device was found to be dimensionally within specification as per (b)(4).-medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant concluded: "in summary, although the exact cause of the problem cannot be completely resolved due to lack of detailed information, it is quite certain that the problem has been caused by an adverse mix of predominantly procedure-related factors with possibly an additional potential additional patient-related factor related to patient obesity.This pi case is not device-related.Procedure-related factors: - incomplete seating of mdm liner during arthroplasty.Patient-related factors: - obesity ((b)(6)) may adversely influence surgical exposure.Device-related factors: - as also confirmed by explant inspection.Diagnosis: - procedure-related factors as cause for potential problems with insert placement were discussed and one or more of these factors was responsible for the incomplete mdm liner seating that required revision." -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: a medical review was performed and concluded: "procedure-related factors as cause for potential problems with insert placement were discussed and one or more of these factors was responsible for the incomplete mdm liner seating that required revision." the returned device was determined to be dimensionally compliant.No further investigation is required at this time.Cause.If additional relevant information becomes available, this investigation will be reopened.

Event Description

As per sales rep, mdm liner was implanted and was revised next day due to post-op x-ray image that showed liner was not engaged.

• 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 colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5915868
• MDR Text Key: 53551200
• Report Number: 0002249697-2016-02803
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/02/2016

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: 01/31/2021
• Device Catalogue Number: 626-00-46F
• Device Lot Number: 54368203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2016
• Initial Date FDA Received: 08/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2016
• 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: 68 YR