MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA V40-FEMORAL HEAD 28MM, +0MM NK; IMPLANT

Catalog Number 6565-0-128

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Fall (1848); Pain (1994); Ambulation Difficulties (2544)

Event Date 06/02/2015

Event Type  Injury  

Event Description

After the tha with trident ceramic liner and ceramic head, the patient felt pain and squeaking.The patient fell down once.Inclinatio pelvis is high.Revision surgery will be performed on (b)(6) 2015.

Manufacturer Narrative

The catalog number and lot code were not provided.The device was reported as alumina ceramic head v40(6565-0-xxx).A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

An event regarding audible noise and pain involving a ceramic head was reported.The event was confirmed for audible noise and dislocation.Method & results: a visual inspection was performed as part of the material analysis report.Metal transfer from likely contact with the titanium sleeve was observed on the articulating surface.The metal transfer marks on the distal side of the head are likely from the removal of the head from the stem.A metal transfer mark around the internal circumference of the female taper was observed indicating that the head was properly seated on the male trunnion of the hip stem.The material analysis report concluded that: no material or manufacturing defects were observed on the surfaces examined.Impingement damage was observed on the trident insert.The ceramic insert broke along the edge where the femoral head rode high on the insert/sleeve.Edge loading is a known contra-indicated condition for this product.A review of the provided information by a clinical consultant indicated that: cup malposition in excessive inclination has contributed to impingement between stem neck and cup rim leading to subluxation of the ceramic femoral head from the ceramic liner causing point contact with an extreme overload condition in the bearing.Ceramic fracture of the liner was the end point of failure leading to revision.Findings confirmed by mar.All devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the reported lot.Conclusions: a review by a clinical consultant concluded that "cup malposition in excessive inclination has contributed to impingement between stem neck and cup rim leading to subluxation of the ceramic femoral head from the ceramic liner causing point contact with an extreme overload condition in the bearing.Ceramic fracture of the liner was the end point of failure leading to revision.".If additional information becomes available, this investigation will be reopened.

Event Description

After the tha with trident ceramic liner and ceramic head, the patient felt pain and squeaking.The patient fell down once.Inclinatio pelvis is high.Revision surgery will be performed on (b)(6) 2015.

• Brand Name: ALUMINA V40-FEMORAL HEAD 28MM, +0MM NK
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK (MDR); ida industrial estate; carrigtwohill NA
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4869725
• MDR Text Key: 6060031
• Report Number: 0002249697-2015-02090
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K023901
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2011
• Device Catalogue Number: 6565-0-128
• Device Lot Number: 24163401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2007
• 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