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

Model Number	690-00-22E
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	11/13/2019
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.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
It was reported that the patient is scheduled to undergo a 6th revision of her right hip due to dislocation (see cross references for all previous revisions) on 14/november/2019.Rep was not made aware of which device(s) dislocated or disassociated.The surgeon cannot offer any explanation as to the possible cause or contributor to dislocation as every time the patient is revised, an extreme rom is tested successfully prior to surgery completion.The acetabular shell and two screws (implanted (b)(6) 2019), liner and femoral head (both implanted (b)(6) 2019) were revised to a new femoral head and bipolar construct with the expectation that further dislocations will be better managed.Rep will try to provide the revision usage data, may be able to provide dislocation details, and reported that no further information will be available.
Additional Manufacturer Narrative
Additional information: added explant date.An event regarding revision due to disassociation involving a trident liner was reported.The event was not confirmed.Device evaluation and results: not performed as product was not returned.Clinician review: no medical records were received for review with a clinical consultant.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 and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
It was reported that the patient is scheduled to undergo a 6th revision of her right hip due to dislocation (see cross references for all previous revisions) on (b)(6) 2019.Rep was not made aware of which device(s) dislocated or disassociated.The surgeon cannot offer any explanation as to the possible cause or contributor to dislocation as every time the patient is revised, an extreme rom is tested successfully prior to surgery completion.The acetabular shell and two screws (implanted (b)(6) 2019), liner and femoral head (both implanted (b)(6) /2019) were revised to a new femoral head and bipolar construct with the expectation that further dislocations will be better managed.Rep will try to provide the revision usage data, may be able to provide dislocation details, and reported that no further information will be released by the hospital or surgeon.Update 22/january/2020 wg: rep confirmed that revision did take place on (b)(6) 2019.The rep was unable to discover which device(s) dislocated or disassociated from each other.Rep provided the revision usage sheet and re- confirmed that no further information will be available.

• Brand Name: TRIDENT 0 DEG CONSTRAINED INSERT 22E
• 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: 9452558
• Report Number: 0002249697-2019-03998
• Device Sequence Number: 2606684
• Product Code: KWZ
• UDI-Device Identifier: 07613327025545
• UDI-Public: 07613327025545
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 02/13/2020

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: 03/31/2023
• Device Model Number: 690-00-22E
• Device Catalogue Number: 690-00-22E
• Device Lot Number: T075RD
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 02/13/2020
• 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: 65 YR
• Patient Weight: 56