MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +4 V40 TAPER VIT HEAD; IMPLANT

Catalog Number 6260-5-232

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Toxicity (2333)

Event Date 11/21/2014

Event Type  Injury  

Event Description

It was reported patient was revised on left hip due to pain and high cobalt level.

Manufacturer Narrative

Additional devices listed in this report: cat 623-00-32f trident 0 degree insert 32mm id lot code unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.It was noted that the devices are not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report.Hospital policy.

Manufacturer Narrative

An event reporting pain and high cobalt levels (altr) involving a metal femoral head was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the reported device was not returned for evaluation.Medical records received and evaluation: a medical review was not performed because insufficient information was provided.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes, pathology reports x-rays and return of the device are needed to fully investigate the event.

Event Description

It was reported, patient was revised on left hip due to pain and high cobalt level.

• Brand Name: 32MM +4 V40 TAPER VIT HEAD
• Type of Device: 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4343459
• MDR Text Key: 5180683
• Report Number: 0002249697-2014-04774
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2014

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 Expiration Date: 04/30/2011
• Device Catalogue Number: 6260-5-232
• Device Lot Number: 18170405
• Other Device ID Number: STERILE LOT 0604DC4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2015
• Initial Date FDA Received: 12/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2006
• 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): Required Intervention
• Patient Age: 81 YR