MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_JTRITANIUM ACETABULAR CUP; HIP IMPLANT

Catalog Number UNK_JR

Device Problems Osseointegration Problem (3003); Migration (4003)

Patient Problems Injury (2348); Inadequate Osseointegration (2646)

Event Date 06/12/2017

Event Type  Injury  

Manufacturer Narrative

This event was reported through an attorney, as a result of a legal claim.  due to the ongoing litigation, no additional information is available at this time.  it was noted that the device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Device evaluated by mfr: device not available.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient was implanted with a tritanium acetabular cup in her right hip on (b)(6) 2016 and was revised on (b)(6) 2017.It is further alleged that during revision surgery, there was micro motion of the acetabular cup and lack of bony ingrowth such that the acetabular cup was removed with zero lone loss to the acetabulum itself.

• Brand Name: UNKNOWN_JTRITANIUM ACETABULAR CUP
• Type of Device: HIP IMPLANT
• 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: joanne mahony ; ida industrial estate; carrigtwohill NA ; 214532800
• MDR Report Key: 8753391
• MDR Text Key: 149800157
• Report Number: 0002249697-2019-02493
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2019
• 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