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

Catalog Number 625-0T-32E

Device Problems Material Deformation (2976); Material Integrity Problem (2978); Noise, Audible (3273)

Patient Problems Pain (1994); Injury (2348)

Event Date 05/13/2015

Event Type  Injury  

Event Description

Left hip revision for pain and audible squeak.Ceramic head and ceramic insert revised to ceramic head and poly insert.

Manufacturer Narrative

Catalog number unknown at this time.Device description reported as unknown trident ceramic insert.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

An event regarding audible noise involving a trident liner was reported.The event was confirmed for impingement from the device analysis and as per medical review "impingement usually causes subluxation which is one very important factor to cause squeaking." method & results: -device evaluation and results: "visual inspection was performed as part of the material analysis report (mar).Images of the device are included in the mar."images of the articulating surface of the trident insert are shown in figures 3 and 4.Evidence of femoral neck impingement damage was observed on the rim of the sleeve component.A wear scar was observed near the rim of the articulating insert surface (figure 4).An overall image of the proximal surface of the trident insert is shown in figure 5." the mar concluded that "no material or manufacturing defects were observed on any of the components examined.Both the ceramic head and insert showed evidence of wear scars.The surface roughness, diameter and sphericity measurement results on the femoral head and insert were consistent with in-vivo service." -medical records received and evaluation: a medical review was performed and concluded: "relative or absolute cup malposition in low anteversion causing impingement with pain in the hip and wear scars on the ceramic surfaces as suggested by the x-ray information and confirmed by the mar findings" -device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: review indicated there has been no other similar events for the reported lot.Conclusions: a medical review was performed and concluded that "relative or absolute cup malposition in low anteversion causing impingement with pain in the hip and wear scars on the ceramic surfaces".The medical review also indicated that there was no evidence the case was device related.Further to this a material analysis concluded that "no material or manufacturing defects were observed on any of the components examined." no further investigation is required at this time.If further information becomes available this investigation will be re-opened.

Event Description

Left hip revision for pain and audible squeak.Ceramic head and ceramic insert revised to ceramic head and poly insert.

• 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: 4828126
• MDR Text Key: 5836700
• Report Number: 0002249697-2015-01863
• 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,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/13/2015

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: 07/31/2008
• Device Catalogue Number: 625-0T-32E
• Device Lot Number: U6268501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/13/2015
• Initial Date FDA Received: 06/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2003
• 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