MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION MODULAR STEM; HIP IMPLANT

Catalog Number UNK_SHC

Device Problems Contamination (1120); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Injury (2348)

Event Date 04/25/2017

Event Type  Injury  

Manufacturer Narrative

The unknown head was also listed in this report.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.A supplemental report will be submitted upon completion of the investigation.

Event Description

Sales rep reported a revision surgery including an extraction of a modular restoration of the left leg due to infection.

Manufacturer Narrative

Device not returned.An event regarding infection involving an unknown restoration modular stem was reported.The event was not confirmed.Method & results: device evaluation and results: a visual, dimensional and functional inspection was not performed as the device was not returned for evaluation.Medical records received and evaluation: no medical information was received for review with the clinical consultant.Device history review could not be performed as the device lot is unknown.Complaint history review could not be performed as the device lot is unknown.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device details, return of device, pathology reports, operative reports, xrays, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.A capa trend analysis was conducted for the reported failure mode and concluded infection is a known possible adverse outcome of surgery and is beyond stryker's control.

Event Description

Sales rep reported a revision surgery including an extraction of a modular restoration of the left leg due to infection.

• Brand Name: RESTORATION MODULAR STEM
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6586142
• MDR Text Key: 75815179
• Report Number: 0002249697-2017-01614
• Device Sequence Number: 1
• Product Code: JDI
• 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,Followup
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2017
• 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: 44 YR
• Patient Weight: 91