MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 32/0° POLY LINER; HIP IMPLANT

Catalog Number UNK_JR

Device Problem Material Deformation (2976)

Patient Problems Inflammation (1932); Discomfort (2330); Injury (2348); Reaction (2414); Inadequate Osseointegration (2646)

Event Date 11/26/2007

Event Type  Injury  

Manufacturer Narrative

If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.

Event Description

It was reported through the attorney for the patient, as a result of a legal claim, that allegedly the patient received a trident acetabular hip system.It was further alleged that, the patient is experiencing "loosening and discomfort" from the system.Update from medical review: a revision of the right total hip arthroplasty acetabular component was performed for a diagnosis of acetabular loosening and metallosis.The liner showed "anterior impingement".The stem was retained as the taper was noted to be "acceptable".

Manufacturer Narrative

An event regarding rom (impingement) involving an unknown liner was reported.The event was confirmed by medical review.Method & results: product evaluation and results: not performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant revealed: ¿on (b)(6) 2007 a revision of the right total hip arthroplasty acetabular component was performed for a diagnosis of acetabular loosening and metallosis.The operative report describe general anesthesia and a posterior approach.The femoral head was removed and the taper was noted to be "acceptable".The stem was retained.Specimens were sent for culture and sensitivity.The liner was removed, as well as the shell, and the liner showed "anterior impingement".Anterior and posterior columns were intact and the acetabulum was reamed to 58 millimeters.Allograft was placed in the base of the defect, and a 60 trident titanium hemispherical cup with four screws, a 60cc fresh frozen allograft, and a 40/0° x3 insert were utilized, and a 40/0 lfit head was placed on the retained stem, all by uncomplicated surgery." ¿in this noncompliant, hypothyroid smoker with compromised acetabular bone stock, failure of biologic fixation of the acetabular component was not unexpected as explained to the patient prior to the primary hip arthroplasty.No x-rays prior to the (b)(6) 2007 revision demonstrating the loose acetabular component are available.There is no evidence that factors of faulty component manufacturing or materials were responsible for the revision surgery three years post-implantation in this case.¿ product history review: a review of the device history records could not be performed as no lot information was provided.Complaint history review: a complaint history review could not be performed as no lot information was provided.Conclusions: the investigation confirmed the event of rom (impingement) however, the root cause could not be confirmed because insufficient information was provided.Further information is needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported through the attorney for the patient, as a result of a legal claim, that allegedly the patient received a trident acetabular hip system.It was further alleged that, the patient is experiencing "loosening and discomfort" from the system.Update from medical review: a revision of the right total hip arthroplasty acetabular component was performed for a diagnosis of acetabular loosening and metallosis.The liner showed "anterior impingment".The stem was retained as the taper was noted to be "acceptable".

• Brand Name: UNKNOWN 32/0° POLY LINER
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8373697
• MDR Text Key: 137255601
• Report Number: 0002249697-2019-01207
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/30/2019

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: 01/30/2019
• Initial Date FDA Received: 02/27/2019
• Supplement Dates Manufacturer Received: 04/02/2019
• Supplement Dates FDA Received: 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 70