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

Model Number	626-00-46F
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "explanted mdm cup/ liner and accolade stem and head.Replaced with new mdm cup and liner and restoration modular stem / cone body and head.No more information given out by hospital/ surgeon." spoke to rep.Rep was not made aware of any patient complaints or other cause for revision.However, intraoperatively it was noted that the ceramic head wore through the adm/ mdm poly insert and the mdm metal liner.Rep provided explant pictures and confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Reported event: an event regarding wear involving a mdm liner.The event was confirmed through visual evaluation of the provided photograph.Method & results: -device evaluation and results: no product was returned for evaluation however a photograph was provided.The photograph shows a recently explanted mdm liner.A hole is visible on the side of the liner.-clinician review: no medical records were received for review with a clinical consultant -product history review: not performed as the device lot details were not provided.-complaint history review: not performed as the device lot details were not provided.Conclusion: the exact cause of the event cannot be confirmed as insufficient information was provided.Further information such as device lot identification and return, pre- and post-operative x-rays, primary operative report as well as patient history and follow-up notes 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
As reported: "explanted mdm cup/ liner and accolade stem and head.Replaced with new mdm cup and liner and restoration modular stem / cone body and head.No more information given out by hospital/ surgeon." spoke to rep.Rep was not made aware of any patient complaints or other cause for revision.However, intraoperatively it was noted that the ceramic head wore through the adm/ mdm poly insert and the mdm metal liner.Rep provided explant pictures and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: MODULAR DUAL MOBILITY INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14734684
• Report Number: 0002249697-2022-00859
• Device Sequence Number: 6047591
• Product Code: LZO
• UDI-Device Identifier: 04546540666024
• UDI-Public: 04546540666024
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K103233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2022

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 Model Number: 626-00-46F
• Device Catalogue Number: 626-00-46F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 140 KG