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 Problem Osseointegration Problem (3003)

Patient Problems Pain (1994); Discomfort (2330); Injury (2348); Inadequate Osseointegration (2646)

Event Date 05/24/2019

Event Type  Injury  

Manufacturer Narrative

The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported that allegedly the patient was implanted with a tritanium acetabular cup in her right hip on (b)(6) 2016 and began experiencing pain and discomfort.It is further alleged diagnostic workup revealed device loosening and in light of worsening symptoms she was taken back for revision surgery to her right hip on (b)(6) 2019.Allegedly "during surgery, micromotion of the cup was observed.The revision surgeon noted blackish discoloration at the interface between acetabular cup and liner.The acetabular cup was noted to have been primarily adhered by fibrous tissue".

• 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8887648
• MDR Text Key: 154115990
• Report Number: 0002249697-2019-02823
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 04546540666000
• UDI-Public: 04546540666000
• 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: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 626-00-38D
• Device Lot Number: 53740503
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2015
• 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: 41 YR