MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 3.5 ACCOLADE (127 DEG) SIZE 3.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6021-3535

Device Problems Degraded (1153); Material Deformation (2976)

Patient Problem Injury (2348)

Event Date 11/06/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Was reported through the submission of a revision implant sheet that patient's right hip was revised.A 10° 36mm eccentric f insert was implanted.Update 07/november/2018: spoke to rep.Patient revised due to an issue with the femoral stem, which was found to be notched on the neck.An accolade tmzf stem, 28 -4 head (composition unknown), and mdm/ adm liner construct were revised to a competitor stem and head with a 10° 36mm eccentric f insert.Rep provided an x-ray and explant pictures and reported that additional x-rays, medical records, and further information are not available due to hospital policy.

Manufacturer Narrative

An event regarding rom issues involving a accolade stem was reported.The event was confirmed following clinician review.Method & results: device evaluation and results: visual inspection:the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted accolade stem.From the photographs provided there is evidence of the presence of a notch on the stem neck.Medical records received and evaluation :a review of the provided x-ray by a clinical consultant indicated: the right has one screw in the acetabulum, which is larger than the acetabulum on the left, and is protruding through the medial post-acetabular wall with a suggestion of excessive version.A notch is noted at the base of the medial femoral component neck and is at a site consistent with impingement occurring on the acetabular rim.The choice of a 28/minus-4 head in an mdm construct increases the likelihood of neckimpingement with the resulting notch production on the femoral neck.There is no evidence this clinical situation was the result of factors associated with implant manufacturing or materials.Device history review: not performed as the device lot number is unknown.Complaint history review: not performed as the device lot number is unknown.Conclusions: a review by a clinician noted " the right has one screw in the acetabulum, which is larger than the acetabulum on the left, and is protruding through the medial post-acetabular wall with a suggestion of excessive version.A notch is noted at the base of the medial femoral component neck and is at a site consistent with impingement occurring on the acetabular rim.The choice of a 28/minus-4 head in an mdm construct increases the likelihood of neck impingement with the resulting notch production on the femoral neck.There is no evidence this clinical situation was the result of factors associated with implant manufacturing or materials however, the root cause of the event could not be determined because insufficient information was provided.Further information such as return of device, device lot details, operative reports and additional x-rays are needed to investigate this event further.If additional information become available, this investigation will be reopened.Product surveillance will continue to monitor for trends.

Event Description

Was reported through the submission of a revision implant sheet that patient's right hip was revised.A 10° 36mm eccentric f insert was implanted.Update (b)(6) 2018: spoke to rep.Patient revised due to an issue with the femoral stem, which was found to be notched on the neck.An accolade tmzf stem, 28 -4 head (composition unknown), and mdm/ adm liner construct were revised to a competitor stem and head with a 10° 36mm eccentric f insert.Rep provided an x-ray and explant pictures and reported that additional x-rays, medical records, and further information are not available due to hospital policy.A review of the provided medical information by a clinician noted the following; the choice of a 28/minus-4 head in an mdm construct increases the likelihood of neck impingement with the resulting notch production on the femoral neck.There is no evidence this clinical situation was the result of factors associated with implant manufacturing or materials.Update (b)(6) 2018: unknown bone screw added to the product grid, a clinician review has stated that "the right has one screw in the acetabulum, which is larger than the acetabulum on the left, and is protruding through the medial post-acetabular wall".

• Brand Name: ACCOLADE (127 DEG) SIZE 3.5 ACCOLADE (127 DEG) SIZE 3.5
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8133831
• MDR Text Key: 129353292
• Report Number: 0002249697-2018-03904
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540510754
• UDI-Public: 04546540510754
• Combination Product (y/n): N
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2019

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: 6021-3535
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2018
• Initial Date FDA Received: 12/05/2018
• Supplement Dates Manufacturer Received: 01/09/2019
• Supplement Dates FDA Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR