MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG CONSTRAINED INSERT 22D; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	690-00-22D
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	10/08/2018
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 reported lot.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Failure of the trident 0 degree constraint liner.Per sales rep., "the inner mechanism dislodged from the outer shell of the constraint liner.".
Additional Manufacturer Narrative
An event regarding disassociation involving a trident liner was reported.The event was confirmed through clinician review of the medical records provided.Method & results: product evaluation and results: the trident liner was returned for evaluation.The head had disassociated from the liner.The retaining ring was also detached from the liner.Damage consistent with explantation process is visible on the device.Clinician review: a review of the provided medical records revealed: on (b)(6) 2018 an x-ray report of the left hip notes, ¿dislocated of left hip replacement demonstrated¿.An additional (b)(6) 2018 x-ray report of the left hip notes, ¿dislocated left hip replacement has been reduced¿.X-ray printouts available for review include an undated ap of the left hip and proximal two-thirds of the femur labeled ¿portable pre-op¿, which demonstrates a dislocated outer bearing of a constrained total hip replacement with a total femoral replacement, two screws in the acetabulum, an intact locking ring of the constrained liner, which is in situ adjacent to the acetabulum from which the outer bearing is dislocated.Another undated ap of the left hip and proximal two-thirds of the femur labeled ¿post-operative portable¿ demonstrates the same femur and acetabulum with the hip reduced with a possible mdm bearing, a deep drain and skin staples in situ.Eleven photographs of disassociated explanted constrained liner components and an intact metallic head include a locking ring and inner and outer bearings, which are all grossly intact.No operative reports, no clinical or past medical history, and no examination of the explanted components are available.In this salvage surgery with compromised soft tissues, stability to the hip joint likely is compromised resulting in impingement at the extremes of motion, which resulted in levering out of the outer bearing of the constrained liner.Malposition may also have contributed to this event.There is no evidence that factors associated with manufacturing or material anomalies contributed to this event.Product history review: indicated 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 lot referenced.Conclusion: the medical review indicated eleven photographs of disassociated explanted constrained liner components and an intact metallic head include a locking ring and inner and outer bearings, which are all grossly intact.No operative reports, no clinical or past medical history, and no examination of the explanted components are available.In this salvage surgery with compromised soft tissues, stability to the hip joint likely is compromised resulting in impingement at the extremes of motion, which resulted in levering out of the outer bearing of the constrained liner.Malposition may also have contributed to this event.There is no evidence that factors associated with manufacturing or material anomalies contributed to this event.It is noted that dislocation of the hip occurred as a result of disassociation of the constrained liner.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
Failure of the trident 0 degree constraint liner.Per sales rep., "the inner mechanism dislodged from the outer shell of the constraint liner.".

• Brand Name: TRIDENT 0 DEG CONSTRAINED INSERT 22D
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8059862
• Report Number: 0002249697-2018-03691
• Device Sequence Number: 2879247
• Product Code: KWZ
• UDI-Device Identifier: 07613327025538
• UDI-Public: 07613327025538
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2019

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: 02/28/2023
• Device Catalogue Number: 690-00-22D
• Device Lot Number: 262908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 05/21/2019
• 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: 62 YR
• Patient Weight: 52