MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE 132 SIZE 3.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 6020-3535

Device Problems Degraded (1153); Material Separation (1562); Naturally Worn (2988)

Patient Problem Injury (2348)

Event Date 11/04/2019

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

It was reported that the patient's right hip was revised due to disassociation of the femoral head from the stem.Intra-operatively, excessive trunnion wear and liner wear were noted.The stem, head and liner were revised.Rep has some additional pictures, and reported that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

An event regarding wear & disassociation involving an accolade stem was reported.The event was confirmed through visual inspection.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 stem with evidence of trunnion wear, which would have resulted in a loss of taper lock and subsequent disassociation of the head from the stem.There is also a significant amount of biological matter present on the device and evidence of boney ongrowth.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

It was reported that the patient's right hip was revised due to disassociation of the femoral head from the stem.Intra- operatively, excessive trunnion wear and liner wear were noted.The stem, head and liner were revised.Rep has some additional pictures, and reported that no further information will be released by the hospital or surgeon.

• Brand Name: ACCOLADE 132 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: 9394592
• MDR Text Key: 169242566
• Report Number: 0002249697-2019-03922
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540510624
• UDI-Public: 04546540510624
• 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: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Model Number: 6020-3535
• Device Catalogue Number: 6020-3535
• Device Lot Number: 32017606
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 88