MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN MDM/ ADM POLY INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number UNK_SHC

Device Problems Degraded (1153); Material Erosion (1214)

Patient Problem Insufficient Information (4580)

Event Date 05/23/2022

Event Type  Injury  

Manufacturer Narrative

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.

Event 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.

Manufacturer Narrative

Reported event an event regarding wear involving an unknown adm 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 for review.The photograph shows an adm liner.Wear/damage 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 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 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: UNKNOWN MDM/ ADM POLY INSERT
• Type of Device: 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 14737788
• MDR Text Key: 294586346
• Report Number: 0002249697-2022-00862
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 140 KG