MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; IMPLANT

Catalog Number 625-0T-32E

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 10/06/2014

Event Type  Injury  

Event Description

It was reported that patient is experiencing left hip pain and instability.Patient will be revised on (b)(6) 2014.

Manufacturer Narrative

Additional devices listed in this report: cat 6021-0130 accolade plus tmzf hip stem #1, lot code 11573401.Cat 6565-0-232 alumina v40 femoral head 32mm, +4mm nk, lot code 16712301.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 as they remain implanted.Additional information has been requested and if received, will be provided in the supplemental report.Remain implanted.

Manufacturer Narrative

(b)(6).An event regarding instability involving a ceramic head was reported.The event was not confirmed.-medical records received and evaluation: a review of the provided information by a clinical consultant could not confirm the event nor determine a root cause.Issue with two ceramic femoral head revisions in 2006 and 2014 due to pain and instability in a (b)(6) female patient with near normal body weight.Revision surgery in 2006 ((b)(4)) was for a ¿failed implant¿ with ¿instability¿ as implanted in 2005 and included femoral head shortening from a 32-mm/+4 to a 32-mm/-4 femoral head.The second revision in 2014 ((b)(4)) concerned a ceramic femoral head revision again due to pain and instability now some 8-years post previous revision of 2006.No information is available about the revision procedure in 2014.Primary arthroplasty in 2005 was for degenerative joint disease and congenital hip dysplasia using bone graft for acetabular reconstruction during arthroplasty.No x-rays are available for review and no implants were returned for investigation.The revision surgical record of 2006 provides technical details about the procedure but no information on indication or clinical problems present other than ¿failed implant¿ and ¿instability¿.Failure in 2006 had the same root cause as the failure in 2014 but revision surgery in 2006 made things only worse by shortening the femoral neck of the device only leading to a new revision as caused by an adverse mix of patient-related factors regarding diseased anatomy of the hip plus procedure-related factors regarding most probably suboptimal component position since 2005 and additional joint laxity induced by the previous hip revision in 2006 for a similar problem of reported instability.Device-related factors have no place in such a scenario as already evident form the classification that only recognizes patient-related and procedure-related factors.As far as the information goes, the femoral head was normal when exchanged only for biomechanical reasons related to joint instability and as such would also preclude devicerelated factors from entering the equation.As such, both pi case (b)(4) are not device-related but caused by an adverse mix of patient-related and procedure-related factors, the nature of which cannot be further detailed due to especially the lack of radiographic information.-device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review indicated there has been one 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 return of device, x-rays, patient history, progress notes is needed to fully investigate the event.

Event Description

It was reported that patient is experiencing left hip pain and instability.Patient will be revised on (b)(6) 2014.

• Brand Name: TRIDENT ALUMINA INSERT
• 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: 4215494
• MDR Text Key: 5000313
• Report Number: 0002249697-2014-04079
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000013
• 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: 10/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2010
• Device Catalogue Number: 625-0T-32E
• Device Lot Number: 14350903
• Other Device ID Number: STERILE LOT 0507EIRA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2005
• 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): Other
• Patient Age: 65 YR
• Patient Weight: 64