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 Problem Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Joint Dislocation (2374); Ambulation Difficulties (2544)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient's left hip was revised due to dissociation of the femoral head from the adm/ mdm poly insert.Cause of dissociation reported as the patient falling 15 feet from a tree stand while hunting.The poly insert and femoral head were revised to another poly insert and femoral head with sleeve.

Event Description

It was reported that the patient's left hip was revised due to dissociation of the femoral head from the adm/ mdm poly insert.Cause of dissociation reported as the patient falling 15 feet from a tree stand while hunting.The poly insert and femoral head were revised to another poly insert and femoral head with sleeve.

Manufacturer Narrative

Reported event: an event regarding disassociation involving a adm liner was reported.The event was confirmed following review of photographs provided.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs note the following: review of the provided photographs clearly show a liner with a deformation on one side and a rupture of the liner in that area.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate 16 devices were manufactured and accepted into final stock on 01 july 2020 with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the investigation confirmed the reported event and root caused was determined to be due to a patient fall.No further investigation for this event is possible at this time.If devices and / or 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: 11054240
• MDR Text Key: 223168837
• Report Number: 0002249697-2020-02738
• 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,other
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 1236-2-848
• Device Catalogue Number: 1236-2-848
• Device Lot Number: 57352001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR