MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA SOLID BACK 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	540-11-52E
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	06/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Loose accolade tmzf femoral stem with mis positioned acetabular liner with alumina ceramic in ceramic bearing.Correction 15/june/2020 wg: spoke to rep.The shell was malpositioned, not the alumina liner.
Event or Problem Description
Loose accolade tmzf femoral stem with mis positioned acetabular liner with alumina ceramic in ceramic bearing.Correction 15/june/2020 wg: spoke to rep.The shell was malpositioned, not the alumina liner.
Additional Manufacturer Narrative
An event regarding malposition involving a trident shell was reported.The event was confirmed by medical review.Visual inspection of the returned device indicates damage to the outer surface of the shell, nothing else of note could be seen.Dimensional inspection: not performed as the dimensional aspects are not in question.Functional inspection: not performed as the functional aspects are not in question.Material analysis not performed as this event does not relate to material integrity.Clinician review: at the time of surgery, dr.Noted in the indications for surgery that in addition to the loose stem he was not completely pleased with the cup position.The procedure appears to have been performed through a posterior approach.Stripe wear was noted on the ceramic head and there was a presence of metallosis.The stem was grossly loose and removed without complication.As noted, x-rays showed an undated and unlabeled "preop" x-ray showed obvious loosening and subsidence of an accolade tmzf style stem with a ceramic head and a somewhat flat acetabular position.An undated and unlabeled "postop" x-ray showed a revision surgery to a restoration modular conical stem well positioned and fixed and a revised acetabular component now more vertical and more traditionally positioned with increased anteversion adverse event identified loose and subsided accolade tmzf stem requiring revision surgery with non-optimal acetabular component position.Hazards: none clearly related to implant.Conclusion of assessment: the revision surgery was confirmed.The stem was found to be grossly loose and the cup in a non-optimal position that led to impingement.There was squeaking of the alumina-alumina bearing and stripe wear of the revised head.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 exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: TRIDENT PSL HA SOLID BACK 52MM
• 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: 10206333
• Report Number: 0002249697-2020-01315
• Device Sequence Number: 3233356
• Product Code: LPH
• UDI-Device Identifier: 04546540237835
• UDI-Public: 04546540237835
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2020

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: 07/31/2010
• Device Model Number: 540-11-52E
• Device Catalogue Number: 540-11-52E
• Device Lot Number: 31247703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 09/28/2020
• 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: 79 YR