MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL; HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES

Catalog Number	502-11-52E
Medical Device Problem Codes	Malposition of Device (2616); Positioning Problem (3009)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	09/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding disassociation between an accolade stem and metal head involving a trident shell was reported.Review of the medical records by a clinical consultant confirmed malposition of the trident shell.Method & results: product evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 03 january 2019 which indicated: the shell was returned for evaluation.Biological fixation was observed on the shell.Clinician review: a review of the provided medical records by a clinical consultant indicated: cup malposition in low inclination with additional inappropriate use of a 10° cup liner in a cup shell with already low inclination has contributed to an overload condition in the arthroplasty leading to excessive corrosion in the taper junction with gradual loss of taper lock functionality and ultimately disassociation between femoral head and trunnion requiring revision surgery.Product history review: indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: an event regarding disassociation between an accolade stem and metal head was reported.Review of the provided medical records by a clinical consultant confirmed malposition of the trident shell.The shell was returned for evaluation.Biological fixation was observed on the shell.The medical review revealed: cup malposition in low inclination with additional inappropriate use of a 10° cup liner in a cup shell with already low inclination has contributed to an overload condition in the arthroplasty leading to excessive corrosion in the taper junction with gradual loss of taper lock functionality and ultimately disassociation between femoral head and trunnion requiring revision surgery.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient required a hip revision.Update; per received images, it appears the trunnion is worn and head dislocated.Update: as per medical review conclusion: cup malposition in low inclination with additional inappropriate use of a 10° cup liner in a cup shell with already low inclination has contributed to an overload condition in the arthroplasty leading to excessive corrosion in the taper junction with gradual loss of taper lock functionality and ultimately disassociation between femoral head and trunnion requiring revision surgery.

• Brand Name: TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL
• Common Device Name: HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8331633
• Report Number: 0002249697-2019-00976
• Device Sequence Number: 1064661
• Product Code: LPH
• UDI-Device Identifier: 04546540432032
• UDI-Public: 04546540432032
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/12/2019

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: 12/30/2014
• Device Catalogue Number: 502-11-52E
• Device Lot Number: 32180101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 02/12/2019
• 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