MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/52; IMPLANT

Catalog Number 1236-2-852

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Toxicity (2333)

Event Date 01/09/2014

Event Type  Injury  

Event Description

It was reported after patient primary left hip implantation, he was experiencing pain and high cobalt levels.Patient also reported he had two dislocations where the doctor popped hip back in place.First one was in 2009 and second, one year later.He was then revised on (b)(6) 2014.X-ray showed patient still has high cobalt levels after revision and is still experiencing pain.

Manufacturer Narrative

Additional devices listed in this report: cat 626-00-46f restoration dual mobility insert lot code 44487402; cat 2030-6545-1 6.5 cancellous bone screw 45mm lot code mkex96; cat 2030-6535-1 6.5 cancellous bone screw 45mm lot code mkem8h; cat 18-2800 delta c-taper head 28mm+0 lot code 44001302; cat 17-0000e ti sleeve for alumina head lot code mlpv63.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.Device not returned to manufacturer.

Manufacturer Narrative

The patient is (b)(6) in height.An event regarding high cobalt (altr) involving an mdm liner was reported.Conclusion no allegation of failure was made against the reported device, further to this a review of the chemical composition of the device indicated that cobalt is not an element inherent in the device material.Based on the information provided there is no indication that the product reported in this investigation contributed to the event.

Event Description

It was reported after patient primary left hip implantation, he was experiencing pain and high cobalt levels.Patient also reported he had two dislocations where the doctor popped hip back in place.First one was in 2009 and second, one year later.He was then revised on (b)(6) 2014.X-ray showed patient still has high cobalt levels after revision and is still experiencing pain.

• Brand Name: RESTORATION ADM X3 INS 28/52
• 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: 4326267
• MDR Text Key: 5253083
• Report Number: 0002249697-2014-04657
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 1236-2-852
• Device Lot Number: 45444301
• Other Device ID Number: STERILE LOT 1310A281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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: 76 YR
• Patient Weight: 91