MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_JOINT REPLACEMENT_54 SHELL; HIP IMPLANT

Catalog Number UNK_JR

Device Problems Malposition of Device (2616); Positioning Problem (3009)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 10/05/2018

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding multiple dislocations due to instability and impingement involving an unknown shell was reported.Shell malpositioning was confirmed through clinician review of the medical records provided.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: an adverse combination of procedure-related factors including cup malposition with additional inappropriate use of an offset liner plus skirted femoral head with patient-related factors including reduced soft tissue stability of the hip due to previous surgeries and possibly age-related muscular atrophy around the hip has contributed to instability with hip impingement and recurrent dislocation requiring a second revision surgery in 2018 after a previous hip revision in 2015 failed to solve this same problem of instability.Product history review: not performed as no lot information was provided.Complaint history review: not performed as no lot information was provided.Conclusion: a review of the provided medical records by a clinical consultant indicated: an adverse combination of procedure-related factors including cup malposition with additional inappropriate use of an offset liner plus skirted femoral head with patient-related factors including reduced soft tissue stability of the hip due to previous surgeries and possibly age-related muscular atrophy around the hip has contributed to instability with hip impingement and recurrent dislocation requiring a second revision surgery in 2018 after a previous hip revision in 2015 failed to solve this same problem of instability.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that patient's left hip was revised after multiple dislocations due to instability and impingement.Head and liner were revised to include a constrained liner.

• Brand Name: UNKNOWN_JOINT REPLACEMENT_54 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: joanne mahony ; ida industrial estate; carrigtwohill NA ; 214532800
• MDR Report Key: 8032603
• MDR Text Key: 125934880
• Report Number: 0002249697-2018-03595
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• 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: 10/05/2018
• 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: 84 YR
• Patient Weight: 72