MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-CORK SIZE 6 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 6721-0635

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Date 08/10/2020

Event Type  Injury  

Manufacturer Narrative

An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.Catalog numbers and lot codes of other devices listed in this report: unknown 36 +0 biolox v40 head, unknown 36e poly liner, unknown screw 1 of 2, unknown screw 2 of 2.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not available.

Event Description

It was reported that the patient's right hip was revised due to pain.No possible cause or contributor for pain was reported to the rep.An accolade ii stem, biolox head, 36e poly liner and 2 screws were revised to an mdm liner with adm/ mdm poly insert, and competitor femoral components.Surgeon did not report the reason for removing the screws, the shell was retained.Rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: SIZE 6 ACCOLADE II 127 DEG
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; IE NA
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; IE NA
• Manufacturer Contact: daniela davila ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 10493373
• MDR Text Key: 205657299
• Report Number: 0002249697-2020-01796
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540669513
• UDI-Public: 04546540669513
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143085
• 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: 09/04/2020

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 Model Number: 6721-0635
• Device Catalogue Number: 6721-0635
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 09/04/2020
• 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: 70 YR
• Patient Weight: 116