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

Catalog Number 626-00-42E

Device Problems Material Disintegration (1177); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Pain (1994); Injury (2348)

Event Date 05/19/2017

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

Revision of a mobile dual mobility (mdm) liner due to disassociation of the metal head with the polyethylene liner.Noticed radiologically after patient experienced pain and noise on mobility.

Manufacturer Narrative

An event regarding dislocation involving an adm liner & metal head was reported.Conclusion: based on the provided information, the product reported in this investigation did not contribute to the event.The event was reported for dislocation and there is no allegation or evidence of failure against the mdm liner.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted for this product, this record will be reopened.Product surveillance will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product nonconformity or unanticipated hazard.

Event Description

Revision of a mobile dual mobility (mdm) liner due to disassociation of the metal head with the polyethylene liner.Noticed radiologically after patient experienced pain and noise on mobility.Additional information: a review by a clinical consultant identified an unknown exter stem malposition in excessive anteversion the most likely cause of the recurring dislocations.

• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6645696
• MDR Text Key: 77699047
• Report Number: 0002249697-2017-01889
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 04546540666017
• UDI-Public: 04546540666017
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2020
• Device Catalogue Number: 626-00-42E
• Device Lot Number: 53856403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2015
• 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: 72 YR