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

Model Number 1236-2-848

Device Problems Unstable (1667); Detachment of Device or Device Component (2907)

Patient Problems Joint Dislocation (2374); Ambulation Difficulties (2544)

Event Date 11/10/2020

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There has been one other similar events for the lot referenced.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

This pi is for the revision performed on (b)(6) 2020.It was reported that the patient's right hip was revised.Patient dislocated in (b)(6) 2020 and a closed reduction was performed in the er.Patient dislocated again in (b)(6) 2020, could not be closed reduced, and was revised.Intra-operatively, the femoral head was observed to be dissociated from the adm/ mdm poly insert.Surgeon reported the reason the patient was dislocating was performing 'extreme yoga' involving 90° flexion and 90° external rotation.Rep can provide pictures of the explants and confirmed that no further information will be released by the hospital or surgeon.

Event Description

This pi is for the revision performed on (b)(6) 2020.It was reported that the patient's right hip was revised.Patient dislocated on (b)(6) 2020 and a closed reduction was performed in the er.Patient dislocated again on (b)(6) 2020, could not be closed reduced, and was revised.Intra-operatively, the femoral head was observed to be dissociated from the adm/ mdm poly insert.Surgeon reported the reason the patient was dislocating was performing 'extreme yoga' involving 90° flexion and 90° external rotation.Rep can provide pictures of the explants and confirmed that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Reported event: an event regarding revision due to disassociation between adm liner and metal head was reported.The event was not confirmed.Method & results: material analysis, functional and dimensional inspections could not be performed as the device was not returned.  visual inspection - the reported device was not returned however photographs were provided for review.The photographs show a recently explanted device with nothing remarkable to report.Clinical review: no medical records were received for review with a clinical consultant.Product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: an event regarding revision due to disassociation between adm liner and metal head was reported.The event was not confirmed.The exact cause of the event could not be determined because insufficient information was provided.Further information is needed to complete the investigation for determining its 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.

• 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: 10934188
• MDR Text Key: 219136852
• Report Number: 0002249697-2020-02575
• 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: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: 1236-2-848
• Device Catalogue Number: 1236-2-848
• Device Lot Number: 38345201
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 85