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

Catalog Number UNK_JR

Device Problems Unstable (1667); Malposition of Device (2616)

Patient Problem Injury (2348)

Event Date 03/28/2019

Event Type  Injury  

Manufacturer Narrative

An event regarding instability of an unknown shell was reported, through the course of investigation, malposition was confirmed by the consulting clinician.Method & results: product evaluation and results: not performed as no product was returned for evaluation.Clinician review: a review of the provided medical records by a clinical consultant indicated: no patient demographics, no clinical or past medical history, no date or operative report of the primary surgery, and no confirmation of instability is available.There is no revision operative report or examination of explanted components available.There are no serial x-rays prior to (b)(6) 2019.The likely cause of the alleged instability in this case is malposition of the acetabular and/or femoral components as noted in the pre-revision x-rays of (b)(6) 2019.There is no evidence that factors associated with component design, manufacturing or materials were responsible for this clinical situation.Product history review: not performed as no lot information was provided.Complaint history review: not performed as no lot information was provided.Conclusions: a review of the provided medical records by a clinical consultant indicated: no patient demographics, no clinical or past medical history, no date or operative report of the primary surgery, and no confirmation of instability is available.There is no revision operative report or examination of explanted components available.There are no serial x-rays prior to (b)(6) 2019.The likely cause of the alleged instability in this case is malposition of the acetabular and/or femoral components as noted in the pre-revision x-rays of (b)(6) 2019.There is no evidence that factors associated with component design, manufacturing or materials were responsible for this clinical situation.Further information such as device identification and return, pre and post operative x-rays, operative reports as well as patient history and follow up notes are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Device not available.

Event Description

It was reported that the patient's right hip was revised due to instability.A system 12 28mm insert and 28 +0 femoral head were revised to a system 12 32mm insert with a 32 +12 head.Rep provided a revision implant sheet, pre- and post-revision x-rays, and reported that no further information is available.

• Brand Name: UNKNOWN SHELL
• 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8674604
• MDR Text Key: 147211256
• Report Number: 0002249697-2019-02182
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2019
• 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
• Patient Age: 90 YR