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

Catalog Number 1236-2-848

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 11/30/2017

Event Type  Injury  

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.

Event Description

Surgeon implanted an adm liner with a competitor stem and cup on a left hip.This case was a revision of a failed competitor construct.The adm liner was used off label in this construct.The liner subsequently dislocated and the femoral head was articulating directly on the bhr cup through a small gap between the adm liner and the femoral head.

Manufacturer Narrative

An event regarding dislocation involving an adm liner was reported.The event was confirmed based on medical records.Method & results: device evaluation and results: not performed as product was not returned medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: off-label use of a stryker adm insert in a non-stryker bhr cup shell with mismatch in liner retention mechanisms has contributed to later dislocation between the two incompatible systems requiring another revision.Device history review: not performed as lot information was not provided.Complaint history review: not performed as lot information was not provided.Conclusions: a review by a clinician states: "because the dislocation problem was caused by the off-label use of a stryker adm insert in a non-stryker bhr cup shell with mismatching retention mechanisms, principal failure mode is procedure-related given the surgeon¿s choice for such an incompatible combination despite awareness of the potential underlying problems." it is stated in both the ifu (qin 4400) and the surgical technique (mdm-sp-2_rev-1_12998) that other manufacturer¿s devices should not be used together with a stryker system.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Surgeon implanted an adm liner with a competitor stem and cup on a left hip.This case was a revision of a failed competitor construct.The adm liner was used off label in this construct.The liner subsequently dislocated and the femoral head was articulating directly on the bhr cup through a small gap between the adm liner and the femoral head.

• Brand Name: RESTORATION ADM X3 INS 28/48
• 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
• MDR Report Key: 7149984
• MDR Text Key: 95894408
• Report Number: 0002249697-2017-03722
• Device Sequence Number: 1
• Product Code: MEH
• 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,other
• Type of Report: Initial,Followup
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1236-2-848
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR