MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MODULAR DUAL MOBILITY INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Catalog Number	626-00-42E
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Insufficient Information (4580)
Date of Event	10/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the sales rep that the total hip replacement surgery was done on (b)(6) 2023 using trident ii shell with duo mobility liner.During surgery upon impacting the actual metal liner, surgeon was sure that the locking mechanism was engaged, various check was carried out to ensure metal liner was seated.Post op day 2 the metal liner was noticed to be disengage inferiorly via x-ray thus revision surgery is required.Revision is scheduled on (b)(6) 2023.
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.
Event or Problem Description
It was reported by the sales rep that the total hip replacement surgery was done on (b)(6) 2023 using trident ii shell with duo mobility liner.During surgery upon impacting the actual metal liner, surgeon was sure that the locking mechanism was engaged, various check was carried out to ensure metal liner was seated.Post op day 2 the metal liner was noticed to be disengage inferiorly via x-ray thus revision surgery is required.Revision is scheduled on (b)(6) 2023.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving an mdm liner was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection: the device was returned for evaluation.Some light scratches were observed as a result of implantation and explanation of the device.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate 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: it was reported that the patient was revised due to disassociation of the liner from the shell.The device was returned for evaluation.Some light scratches were observed as a result of implantation and explanation of the device.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, and x-rays are needed to fully investigate the event.If further information becomes available , this investigation will be re-opened.

• Brand Name: MODULAR DUAL MOBILITY INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18070555
• Report Number: 0002249697-2023-01334
• Device Sequence Number: 20787359
• Product Code: MEH
• UDI-Device Identifier: 04546540666017
• UDI-Public: 04546540666017
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K103233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2024

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: 626-00-42E
• Device Lot Number: 98913003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 11/04/2023
• Supplement Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown