MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRITANIUM ACETABULAR CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNK_JR

Device Problem Osseointegration Problem (3003)

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

Event Date 02/19/2018

Event Type  Injury  

Manufacturer Narrative

An event regarding loosening involving a tritanium shell was reported.The event was not confirmed.Method & results: product evaluation and results: visual, dimensional, functional and material analysis not be performed as the device is not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of the device history records could not be performed as lot information was not provided.Complaint history review: a complaint history review could not be performed as lot code information was unknown.  conclusions: it was reported that patient was revised due to loosening.The event could not be confirmed nor the exact cause of the event could be determined because insufficient information was available.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.Device not returned.

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 a period of time after the implantation began experiencing discomfort.It is alleged in light of worsening symptoms she was taken for revision surgery on (b)(6) 2018 and "during the revision surgery, it was discovered that the acetabular cup was loose with gross motion and with only a fibrous bond.There was some metallosis around the screws, which was curetted out.There was fluid over the anterior aspect of the hip.".

• Brand Name: UNKNOWN TRITANIUM ACETABULAR CUP
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: collin neitzel ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9794601
• MDR Text Key: 188744346
• Report Number: 0002249697-2020-00463
• Device Sequence Number: 1
• Product Code: LPH
• 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: 03/05/2020

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 Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 03/05/2020
• 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