MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_STRYKER HIP; HIP IMPLANT

Catalog Number UNK_JR

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 01/15/2018

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

In reporting a revision of patient's right hip on (b)(6) 2019 due to pain and possible shell loosening ((b)(4)), rep reported that patient had a revision one year prior due to dislocation.Spoke to rep.The dislocation event involving stryker devices was alleged by the patient.The facility and surgeon are unknown.There is no access to records for the event.The precise nature of the 2018 procedure cannot be determined as the femoral head revised in 2019 appears to have been manufactured approximately 13 years ago (manufacturing date of the revised constrained liner unknown).Neither the rep nor the surgeon who performed the revision in 2019 have access to any further information.

Manufacturer Narrative

Reported event: an event regarding dislocation an unknown hip implant component was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned medical records received and evaluation: medical review was performed in relation to patient's subsequent revision surgery on (b)(6) 2019.This review noted nothing relevant to the dislocation event.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including device details, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

In reporting a revision of patient's right hip on (b)(6) 2019 due to pain and possible shell loosening (pi 1988760), rep reported that patient had a revision one year prior due to dislocation.Spoke to rep.The dislocation event involving stryker devices was alleged by the patient.The facility and surgeon are unknown, there is no access to records for the event.The precise nature of the 2018 procedure cannot be determined as the femoral head revised in 2019 appears to have been manufactured approximately 13 years ago (manufacturing date of the revised constrained liner unknown).Neither the rep nor the surgeon who performed the revision in 2019 have access to any further information.

• Brand Name: UNKNOWN_STRYKER HIP
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8327845
• MDR Text Key: 135854950
• Report Number: 0002249697-2019-00956
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 03/05/2019

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: 01/15/2019
• Initial Date FDA Received: 02/11/2019
• Supplement Dates Manufacturer Received: 02/06/2019
• Supplement Dates FDA Received: 03/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR