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

Model Number 6058-0335D

Device Problem Loss of Osseointegration (2408)

Patient Problems Fall (1848); Injury (2348); Inadequate Osseointegration (2646)

Event Date 07/28/2020

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Doctor reports patient at status post left anterior hip replacement done approximately 2 weeks ago may have fallen and now has an acetabular fracture and the cup has shifted as well as protruded through the medial wall.Doctor requested to revise the acetabulum.The cup was carefully removed and then preparation of the acetabulum was performed to implant a tritanium revision cup.After bone grafting the medial wall the cup was implanted and multiple screws were used to augment it¿s fixation.Satisfied with the cup a liner was impacted.It was then noticed the accolade cemented stem was loose.Doctor decided to re cement a new stem into the existing mantle.A trial head was used to check stability.A new head was implanted and the surgical site was closed.The surgery was performed without incident.No further information is available due to emr password secured.

• Brand Name: ACCOLADE C CS 132 NK
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: alessandra chavez ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 10444634
• MDR Text Key: 204191540
• Report Number: 0002249697-2020-01696
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327020748
• UDI-Public: 07613327020748
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/24/2020

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 Expiration Date: 09/30/2020
• Device Model Number: 6058-0335D
• Device Catalogue Number: 6058-0335D
• Device Lot Number: LL389P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2015
• 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: 94 YR