MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° CROSSFIRE INSERT 36 MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	621-00-36F
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348); Joint Dislocation (2374)
Date of Event	12/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
As reported: "dislocating total hip.Converted to mdm construct".
Event or Problem Description
As reported: "dislocating total hip.Converted to mdm construct".
Additional Manufacturer Narrative
An event regarding dislocation involving a trident insert was reported.The event was confirmed through clinician review of the medical records provided.Method & results: product evaluation and results: not performed as no product was returned for evaluation.Clinician review: a review of the provided medical records by a clinical consultant indicated: this patient with obesity had a revision surgery performed for recurrent dislocation with exchange of the bearing to an mdm construct.The surgery was complicated by an early superficial wound infection requiring irrigation and debridement 10-days post surgery with all devices retained.-product history review: not performed as no lot information was provided.-complaint history review: not performed as no lot information was provided.Conclusion: a review of the provided medical records by a clinical consultant indicated: this patient with obesity had a revision surgery performed for recurrent dislocation with exchange of the bearing to an mdm construct.The surgery was complicated by an early superficial wound infection requiring irrigation and debridement 10-days post surgery with all devices retained.The exact cause of the event cannot be confirmed as insufficient information was provided.Further information such as product lot details and relevant x-ray information is required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIDENT 0° CROSSFIRE INSERT 36 MM 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: 8274509
• Report Number: 0002249697-2019-00324
• Device Sequence Number: 1557372
• Product Code: LPH
• UDI-Device Identifier: 07613327023756
• UDI-Public: 07613327023756
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K021911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2019

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 Catalogue Number: 621-00-36F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/31/2018
• Supplement Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 04/08/2019
• 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: 82 YR
• Patient Weight: 100