MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Catalog Number 625-0T-28D

Device Problems Migration or Expulsion of Device (1395); Scratched Material (3020)

Patient Problem Injury (2348)

Event Date 08/10/2017

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

Tha primary surgery was performed on (b)(6)2010.Then the revision surgery was performed on (b)(6)2017 because the ceramic liner had deviated to superior approximately 5 degrees.All implants except the stem were replaced.

Event Description

Tha primary surgery was performed on (b)(6) 2010.Then the revision surgery was performed on (b)(6) 2017 because the ceramic liner had deviated to superior approximately 5 degrees.All implants except the stem were replaced.

Manufacturer Narrative

An event regarding instability involving a trident liner was reported.The event was not confirmed.Method & results: -device evaluation and results: a visual inspection was performed on the returned device by a material analysis engineer which noted; the proximal and distal surface of the titanium sleeve showed signs of explantation damage.It was observed that the distal surface of the ceramic insert had metal transfer marks likely from explantation.[.] a material analysis was performed on the returned device which concluded [.] the acetabular shell, trident insert and alumina head showed signs of explantation damage.A continuous metal transfer ring was observed on the internal circumference of the female taper consistent with proper seating between of the trunnion of the hip stem and the head taper.No material or manufacturing defects were observed on the surfaces examined.[.] -medical records received and evaluation: a review of the provided x-rays and mar by a clinical consultant noted the following; [.] procedure-related factors: - none evident.Patient-related factors - soft tissue/muscle insufficiency across hip joint.Device-related factors: - none as also supported by mar findings.Diagnosis: - soft tissue/muscle insufficiency across hip joint has contributed to micro-instability in the arthroplasty with micro-separation as result causing an overload condition in the arthroplasty with osteolysis and probably cup loosening requiring revision.[.] -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 similar events for the reported lot.Conclusion: a review of the provided x-rays and mar by a clinical consultant concluded [.] - soft tissue/muscle insufficiency across hip joint has contributed to micro-instability in the arthroplasty with micro-separation as result causing an overload condition in the arthroplasty with osteolysis and probably cup loosening requiring revision.[.] no further investigation for this event is possible at this time.If additional information become available, this investigation will be reopened.

• Brand Name: TRIDENT ALUMINA INSERT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6850187
• MDR Text Key: 85264849
• Report Number: 0002249697-2017-02696
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: P000013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 625-0T-28D
• Device Lot Number: 32889201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Date Manufacturer Received: 12/06/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 45