MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT X3 ECCENTRIC 10° 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	663-10-36I
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Injury (2348); Joint Dislocation (2374)
Date of Event	08/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding involving pain, instability and rom issues were reported.The event was confirmed through clinician review of the provided medical records.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: cup malposition in retroversion and excessive medialization in combination with loss of hip abductor functionality after trochanteric avulsion with capsular laxity after multiple dislocations has contributed to hip instability with pain due to impingement requiring revision with conversion to an adm/mdm cup construct.Device history review: 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 reported lot.Conclusion: the investigation concluded that pain, instability and rom issues were caused by cup malposition in retroversion and excessive medialization in combination with loss of hip abductor functionality after trochanteric avulsion with capsular laxity after multiple dislocations has contributed to hip instability with pain due to impingement requiring revision with conversion to an adm/mdm cup construct.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 patient's left hip was revised.An operative report supplied by the rep indicates "severe pain due to impingement with a retroverted acetabulum.The hip is extremely unstable with combined anteversion of 0.".Patient was revised to an adm/mdm liner construct and a competitor head (stryker shell remained implanted but 1 screw was removed).Update: 07 sep 2018: a review by a clinical consultant has confirmed cup malposition in retroversion and excessive medialization in combination with loss of hip abductor functionality after trochanteric avulsion with capsular laxity after multiple dislocations has contributed to hip instability with pain due to impingement requiring revision.

• Brand Name: TRIDENT X3 ECCENTRIC 10° 36MM ID
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7918713
• Report Number: 0002249697-2018-03120
• Device Sequence Number: 1936180
• Product Code: LPH
• UDI-Device Identifier: 07613327024944
• UDI-Public: 07613327024944
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2018

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: 08/31/2013
• Device Catalogue Number: 663-10-36I
• Device Lot Number: 13NAJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 09/28/2018
• 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: 69 YR
• Patient Weight: 84