MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE STEM; HIP IMPLANT

Catalog Number UNK_JR

Device Problem Metal Shedding Debris (1804)

Patient Problems Inflammation (1932); Injury (2348); Reaction (2414)

Event Date 03/01/2018

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

As reported: "patient was brought in for revision of painful right hip.According to surgeon, patient had elevated ion levels consistent with trunnionosis/ metallosis.Debridement and irrigation of necrotic tissue.Trunnion of accolade i stem inspected and cleaned.Stem was well-fixed and left.A new 36mm universal biolox c-taper femoral head with v-40 to c-taper adapter sleeve was implanted and a new 36mm e eccentric liner was replaced as well.

• Brand Name: UNKNOWN ACCOLADE STEM
• Type of Device: HIP IMPLANT
• 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7378236
• MDR Text Key: 103717330
• Report Number: 0002249697-2018-00917
• Device Sequence Number: 1
• Product Code: MEH
• 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: 03/28/2018

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_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2018
• Initial Date FDA Received: 03/28/2018
• 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: 79 YR