MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° CROSSFIRE INSERT 36 MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU

Catalog Number	621-00-36H
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	05/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: trident psl with purefix ha 62mm; cat# 542-11-62h; lot# 23603601.Acetabular dome hole plug; cat# 2060-0000-1; lot# 7rvmmd.V40(tm).Femoral head; cat# 6364-2-136; lot# g2039956.Exeter v40 stem 50mm no 3; cat# 0580-1-503; lot# g1423462.6.5 cancellous bone screw 25mm; cat# 2030-6525-1; lot# kl5mnd.6.5 cancellous bone screw 25mm; cat# 2030-6520-1; lot# d61mpd.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 device is not available for evaluation.A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Revision hip for possible infection and bursitis.Stem, head, cup and liner removed.Cement spacer implanted.
Additional Manufacturer Narrative
An event regarding infection involving a trident liner was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection of the returned device noted the following: damage consistent with the explantation process was observed on the insert.Impressions were observed on the proximal side of the liner which was consistent with insert/shell contact.Yellow discoloration consistent with absorption of synovial fluid, was also observed on the insert.A higher magnification image of articulating surface shows damage consistent with burnishing, scratching, and third body indentations.The damage modes present on the articulating surface are common damage modes for uhmwpe material analysis of the returned device noted the following: based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: "regarding event description "revision hip for possible infection and bursitis.Cement spacer implanted.Infection clinically confirmed? no" 67y/o male, implanted (b)(6) 2009, explanted (b)(6) 2019, op.Record (b)(6) 2009 right hybrid exeter tha with implant labels.Undated x-ray print-outs 2 ap 1 lat right hip demonstrates a hybrid tha, reduced in nominal position with no gross pathology noted.No op.Reports, no clinical or pmh, no serial images or bacteriology reports.No confirmation of event description.Insufficient data to generate a report." -product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.There have been no other similar events for the sterile lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as bacteriology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Revision hip for possible infection and bursitis.Stem, head, cup and liner removed.Cement spacer implanted.Update: "1.Was the infection clinically confirmed? no.".

• Brand Name: TRIDENT 0° CROSSFIRE INSERT 36 MM ID
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8687083
• Report Number: 0002249697-2019-02212
• Device Sequence Number: 2220489
• Product Code: LZO
• UDI-Device Identifier: 07613327023732
• UDI-Public: 07613327023732
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K991952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2010
• Device Catalogue Number: 621-00-36H
• Device Lot Number: 1ZMCFC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 81