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

Catalog Number UNK_JR

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Injury (2348); Joint Dislocation (2374); Joint Laxity (4526)

Event Date 09/06/2018

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.Device not returned.

Event Description

Quarterly report received as part of the (b)(6) revealed patient id: (b)(6) underwent revision on (b)(6) 2018.Very limited information is included in the quarterly report and an e-mail has been sent out to surgeon and the sales rep as an attempt to get more information.Update 10/december/2018: surgeon provided additional information: "[patient] had a rejuvenate revised years ago at another institution but was dislocating, so the revision was for instability.".

Manufacturer Narrative

Corrected data: it was discovered that the selection for b2 was inadvertently missed during the submission of the initial report.B2 has been updated with the appropriate information.

Event Description

Quarterly report received as part of the 2012-024 iis (clinical and radiographic outcome of the stryker rejuvenate study) revealed patient id: chl1718 underwent revision on 09/06/2018.Very limited information is included in the quarterly report and an e-mail has been sent out to surgeon and the sales rep as an attempt to get more information.Update 10/december/2018: surgeon provided additional information: "[patient] had a rejuvenate revised years ago at another institution but was dislocating so the revision was for instability.".

• Brand Name: UNKNOWN STRYKER HIP
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8204659
• MDR Text Key: 131703036
• Report Number: 0002249697-2018-04183
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention