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

Catalog Number UNK_SHC

Device Problems Corroded (1131); Metal Shedding Debris (1804); Material Integrity Problem (2978)

Patient Problems Pain (1994); Injury (2348)

Event Date 02/10/2017

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that the patient had components implanted (b)(6) 2014 and recently presented with 'pain'.It was reported that the patient had a revision surgery.It was reported that the explanted head and neck components present with black debris.

Manufacturer Narrative

Corrected data: product available to stryker.An event regarding corrosion involving an unknown stem was reported.The event was confirmed.Method & results: --device evaluation and results: not performed as the device was not returned.However a mar conducted on the returned head concluded:- "damage consistent with the explantation process was observed on the head.Discoloration was observed on the taper of the head.Eds showed the discoloration was consistent with a corrosion process, material transfer from a hip stem and biological material.No material or manufacturing defects were observed on the surfaces examined." -medical records received and evaluation: no medical records were received for review with a clinical consultant.-device history review: a review of the device history records could not be performed as the lot id is unknown.-complaint history review: a complaint history review could not be performed as the lot id is unknown.Conclusions: it was reported that the patient was revised due to pain wherein black debris were observed on the explanted devices.A mar conducted on the returned head concluded that discoloration consistent with a corrosion process, material transfer from a hip stem and biological material was observed on the taper of the head.However the root cause of the event could not be determined as sufficient information was not provided.Further information such as device details, return of device, operative reports, x-rays, 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.Not returned to manufacturer.

Event Description

It was reported that the patient had components implanted (b)(6) 2014 and recently presented with 'pain'.It was reported that the patient had a revision surgery.It was reported that the explanted head and neck components present with black debris.

• Brand Name: UNKNOWN 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: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6401452
• MDR Text Key: 69841956
• Report Number: 0002249697-2017-00868
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• 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?: No
• Date Manufacturer Received: 04/06/2017
• 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