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

Catalog Number	643-00-36E
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	01/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.Not available.
Event or Problem Description
Patient was dislocating.Total hip was converted to a mdm construct.
Additional Manufacturer Narrative
An event regarding dislocation involving a trident liner was reported.Instability and dislocation were confirmed following review by a clinical consultant.Method & results: -device evaluation and results: not performed as the reported device was not returned for evaluation.-medical records received and evaluation: a review by a clinical consultant noted: [.] because optimal component position is the responsibility of the surgeon, this factor is procedure-related while the prior hip abductor muscle problems were given prior to the most recent arthroplasty and as such are patient-related.[.] [.] hip instability is determined by the size and position of components in their relationship with the patient¿s anatomy and functional properties of the hip joint and has no relationship with materials or manufacturing related properties of the devices implanted.This pi case is not device-related.-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.Conclusions: a review by a clinical consultant concluded: suboptimal cup position in combination with hip abductor insufficiency have contributed to hip instability requiring revision of a standard trident liner to a mdm construct.If further information becomes available and/or the product is returned, this investigation will be re-opened.
Event or Problem Description
Patient was dislocating.Total hip was converted to a mdm construct.

• Brand Name: TRIDENT X3 ELEVATED RIM 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: 6356961
• Report Number: 0002249697-2017-00660
• Device Sequence Number: 829974
• Product Code: LPH
• UDI-Device Identifier: 07613327025064
• UDI-Public: (01)07613327025064(11)161018(17)211031(10)HL5XMJ
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2017

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: 10/31/2021
• Device Catalogue Number: 643-00-36E
• Device Lot Number: HL5XMJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/26/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2017
• Supplement Report FDA Received Date: 04/11/2017
• 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: 64 YR
• Patient Weight: 77