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

Model Number	626-00-42E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
This pi is for revision of the patient's right hip in (b)(6) 2019.In (b)(6) 2019, a hemi hip construct was converted to a total hip (universal bipolar component head removed, a sleeve, head, adm/ mdm poly insert, mdm metal insert, shell, and screws were implanted.In (b)(6) 2019, patient's liner was converted to a constrained liner.The reason for both revisions was not reported to the rep.
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.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.The following devices were also listed in this report: cat# 1236-2-848; restoration adm x3 ins 28/48; lot# 67559801; cat# 6519-1-028; delta un.Fem hd 28mm r28 16/18; lot# 61914801; cat# 6519-t-100; uni adaptor sleeve v40 ti; lot# 67079507.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.H3 other text : not returned to the manufacturer.
Additional Manufacturer Narrative
Reported event: an event regarding revision involving an mdm liner was reported.The event was confirmed as implant sheets were provided for review, however, the reason for revision is unknown as no hazard or harm was reported.Method & results : product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were provided 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's mdm liner was revised.The event was confirmed as implant sheets were provided for review, however, the reason for revision is unknown as no hazard or harm was reported.Further information such as the reason for the revision surgery, pre- and post-operative x-rays, revision operative report as well as return of the device are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
This pi is for revision of the patient's right hip in (b)(6) 2019.In (b)(6) 2019, a hemi hip construct was converted to a total hip (universal bipolar component head removed, a sleeve, head, adm/ mdm poly insert, mdm metal insert, shell, and screws were implanted.In (b)(6) 2019, patient's liner was converted to a constrained liner.The reason for both revisions was not reported to the rep.

• 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
• 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: 17296602
• Report Number: 0002249697-2023-00763
• Device Sequence Number: 12514766
• Product Code: MEH
• UDI-Device Identifier: 04546540666017
• UDI-Public: 04546540666017
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K103233
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2023

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: 09/30/2023
• Device Model Number: 626-00-42E
• Device Catalogue Number: 626-00-42E
• Device Lot Number: 67788302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/01/2019
• Supplement Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 85 KG