MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/52; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Catalog Number 1236-2-852

Device Problems Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 06/13/2018

Event Type  Injury  

Manufacturer Narrative

If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.

Event Description

Dual mobility v40 ceramic head disassociated from the poly head.The patient felt acute instability while surfing, unable to continue.Called doctor and was advised to get an xray performed.On xray it became clear that the ceramic head was eccentric in the acetabulum and the poly was disassociated.

Manufacturer Narrative

An event regarding dislocation and disassociation involving a mdm liner was reported.Dislocation and disassociation could not be confirmed; however, material analysis of the returned adm liner showed damage consistent with impingement.Method & results: product evaluation and results: material analysis was performed on the returned device.The material analysis report concluded the following: damage consistent with impingement was observed on the distal rim of the insert.Scratching was also observed on the insert, which is a common damage mode of uhmwpe.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: not performed as no medical records were returned for review.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there were no other events for the lot provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as pre- and post-operative x-rays and the 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 as insufficient information was received by stryker orthopaedics.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Dual mobility v40 ceramic head disassociated from the poly head.The patient felt acute instability while surfing, unable to continue.Called doctor and was advised to get an xray performed.On xray it became clear that the ceramic head was eccentric in the acetabulum and the poly was disassociated.

• Brand Name: RESTORATION ADM X3 INS 28/52
• 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: 7678714
• MDR Text Key: 113701040
• Report Number: 0002249697-2018-02139
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 04546540638991
• UDI-Public: 04546540638991
• 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: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1236-2-852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Date Manufacturer Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 77