MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Model Number 1236-2-848

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems Injury (2348); Ambulation Difficulties (2544)

Event Date 08/17/2020

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.

Event Description

It was reported that the patient's left hip was revised due to dislocation of a competitor head and an adm/ mdm poly insert sustained in a fall from bed.The patient's mdm liner, adm/ mdm insert, and competitor head were revised to a constrained liner and competitor femoral head.Rep confirmed that no further information will be released.

Event Description

It was reported that the patient's left hip was revised due to dislocation of a competitor head and an adm/ mdm poly insert sustained in a fall from bed.The patient's mdm liner, adm/ mdm insert, and competitor head were revised to a constrained liner and competitor femoral head.Rep confirmed that no further information will be released.

Manufacturer Narrative

Off-label event reported event: an event regarding disassociation from competitor femoral head involving an adm liner was reported.The event was not confirmed.Method & results: -product evaluation and results: not performed as no product was returned for evaluation.-medical records received and evaluation: not performed as no medical records were received for review.-product history review: indicate 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 lot referenced.Conclusions: an event regarding disassociation from competitor femoral head involving an adm liner was reported.The event was not confirmed.Based on the provided information it has been determined that this event is associated with an off-label application.As per surgical technique , a review of the mdmx3 (modular dual mobility acetabular system) surgical technique mdm-sp-2_rev-1_12998 confirmed that it includes detailed step-by-step instructions on the preparation, sizing, trialing, alignment and implantation of the adm liner.Only stryker 22.2mm or 28mm femoral heads should be inserted into the adm/mdm polyethylene inserts.As only stryker product are compatible with stryker component, using styker component with competitor product is consider as an off label use of products.The event itself could not be confirmed nor could the exact cause of the event be determined because insufficient information was provided.Further information such as product return, pre and post operative x- rays, operative reports as well as patient history and follow up notes are needed to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: RESTORATION ADM X3 INS 28/48
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10507265
• MDR Text Key: 206107956
• Report Number: 0002249697-2020-01814
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 04546540638977
• UDI-Public: 04546540638977
• Combination Product (y/n): N
• PMA/PMN Number: K093644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 1236-2-848
• Device Catalogue Number: 1236-2-848
• Device Lot Number: 69693101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 90