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

Model Number	626-00-46F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Joint Dislocation (2374)
Date of Event	03/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding dislocation and fretting of an mdm liner was reported.The event was not confirmed.Method & results: product evaluation and results: visual, functional, dimensional and material analysis could not be performed as the device was not returned.Clinician review: the available medical records were provided to the consulting clinician for a review which noted," in this large, obese male patient with narcotic dependent chronic pain, it is not possible to determine the cause of the eccentric position of the modular femoral head in the mdm articulation of the right hip without examination of the explanted components and/or a more graphic description of the revision operative findings.Similarly, metalosis cannot be confirmed without a description of the surgical pathology specimen and histopathology report.Based on the information available for review, no determination can be made for the pre-operative radiographic appearance and indication for the right total hip arthroplasty bearing revision performed on (b)(6) 2018.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.Conclusions: it was reported that patient was revised due to failed liner with partial dislocation of right total hip and metalosis.The available medical records were provided to the consulting clinician for a review which was deemed insufficient to confirm the event.The event could not be confirmed nor the exact cause be determined because insufficient information was provided.Additional information are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.
Event or Problem Description
It was reported by the patient's attorney as a result of a legal claim that the patient allegedly had suffered injuries/complications from a failed hip replacement part.Update based on med review: right total hip replacement revision with femoral ceramic head exchange with a sleeve, as well as acetabular component revision" for a diagnosis of "failed liner with partial dislocation of right total hip and metalosis".The operative report describes general anesthesia and a posterior approach.The report notes, " large amount of heterotopic bone posteriorly eventually able to dislocate femoral head removed ceramic head liner had been displaced anteriorly and dislocated this had led to metalosis significant wear on the ceramic head onto the metal edge polyethylene dual mobility liner was removed with some effort metallic sleeve had some scratches.The right hip demonstrates three screws in the acetabulum, a restoration modular stem which appears subsided, and a smaller modular head which appears to be superiorly migrated in an mdm liner.

• Brand Name: MODULAR DUAL MOBILITY INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 12133395
• Report Number: 0002249697-2021-01161
• Device Sequence Number: 4616194
• Product Code: MEH
• UDI-Device Identifier: 04546540666024
• UDI-Public: 04546540666024
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K103233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/08/2021

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: 04/23/2017
• Device Model Number: 626-00-46F
• Device Catalogue Number: 626-00-46F
• Device Lot Number: 40002103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 07/08/2021
• 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: 59 YR