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

Catalog Number UNK_SHC

Device Problem Malposition of Device (2616)

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

Event Date 04/10/2018

Event Type  Injury  

Manufacturer Narrative

An event regarding dislocation involving an mdm liner, adm liner and a metal head was reported.The medical review identified malposition of an unknown trident shell as the root cause of the dislocation.Method & results: product evaluation and results: not performed as the device was not returned.Medical records received and evaluation: a review of the provided medical records and/or x-rays by a clinical consultant indicated: conclusion of assessment cup malposition in excessive inclination and superficial placement contributed to an overload condition in the arthroplasty causing recurrent dislocation with the final dislocation being an intraprosthetic dislocation requiring revision surgery about which there is no info.Does the review identify any procedural related factors that contributed to the event? cup malposition is excessive inclination and superficial placement.Does the review identify any patient related factors that contributed to the event? none, the degree of overweight is not very relevant for the failure mode.Does the review identify any device related factors that caused or contributed to the adverse event? no device-related factors are associated with any of the implanted devices.Product history review: not performed as the device lot details were not provided.Complaint history review: not performed as the device lot details were not provided.Conclusions: the medical review concluded: cup malposition in excessive inclination and superficial placement contributed to an overload condition in the arthroplasty causing recurrent dislocation with the final dislocation being an intraprosthetic dislocation requiring revision surgery about which there is no info.No further investigation for this event is required at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.Not returned.

Event Description

It was reported that patient's right hip was revised due to multiple dislocations.Intra-operatively, the head was found to be pulled completely out of the poly liner and was articulating directly against the metal liner with the poly out of the acetabulum.Surgeon could not remove the well-seated metal liner but noted no burnishing or metallosis in the acetabulum.A medical review confirmed use of a trident shell and the malposition of this component.Conclusion of assessment: cup malposition in excessive inclination and superficial placement contributed to an overload condition in the arthroplasty causing recurrent dislocation with the final dislocation being an intraprosthetic dislocation requiring revision surgery about which there is no info.

• Brand Name: UNKNOWN TRIDENT SHELL
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: bradley curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7609392
• MDR Text Key: 111321798
• Report Number: 0002249697-2018-01825
• 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: 06/18/2018

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_SHC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 06/18/2018
• 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: 66 YR
• Patient Weight: 95