MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG INSERT 44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-00-44F
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	01/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
Dr.Revised a total hip - the liner, head and sleeve from a 44 to an mdm due to dislocation.The original surgery date was unknown, however a revision surgery was done on (b)(6) 2011 to address a loose cup.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation involving a trident liner and ceramic head was reported.The event was not confirmed.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/or x-rays by a clinical consultant indicated: no confirmation of dislocation of the left total hip arthroplasty requiring revision surgery on january 9, 2019 is available, but the x-ray suggestion of acetabular malposition may have resulted in impingement and subsequent dislocation from this cause.Examination of the explanted components and additional imaging studies, along with the dictated operative report and findings would be helpful in determining the cause of the instability and rule out factors associated with implant manufacturing or materials.-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: a review of the provided medical records and/or x-rays by a clinical consultant indicated: no confirmation of dislocation of the left total hip arthroplasty requiring revision surgery on january 9, 2019 is available, but the x-ray suggestion of acetabular malposition may have resulted in impingement and subsequent dislocation from this cause.The exact cause of the event could not be determined because insufficient information was provided.Additional information including examination of the explanted components and additional imaging studies, along with the dictated operative report and findings would be helpful in determining the cause of the event and rule out factors associated with implant manufacturing or materials.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Dr.Revised a total hip - the liner, head and sleeve from a 44 to an mdm due to dislocation.The original surgery date was unknown, however a revision surgery was done on (b)(6) 2011 to address a loose cup.

• Brand Name: TRIDENT 0 DEG INSERT 44MM
• 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: 8312688
• Report Number: 0002249697-2019-00667
• Device Sequence Number: 16637511
• Product Code: LPH
• UDI-Device Identifier: 07613327025422
• UDI-Public: 07613327025422
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K062419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2019

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: 11/30/2015
• Device Catalogue Number: 623-00-44F
• Device Lot Number: MJRV41
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 04/22/2019
• 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: 72 YR