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

Catalog Number 1236-2-852

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 02/10/2014

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

Patient called regarding a hip replacement done on (b)(6) 2014.Patient reported pain.

Manufacturer Narrative

An event regarding pain 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 the reported device remains implanted.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: cannot confirm event, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.-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 has been no other similar event for the lot referenced.Conclusion: the event of pain could not be confirmed.Further information such as primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components are required to complete the investigation for determining a root cause.It is noted that a recall query was made regarding the product reported in this event.Based on the catalog and lot number provided the product reported was not subject to a call.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient called regarding a hip replacement done on (b)(6) 2014.Patient reported pain.Spoke to patient, he wants to know if his implants are involved in a recall before he provides additional records.

• Brand Name: RESTORATION ADM X3 INS 28/52
• 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: 8917328
• MDR Text Key: 155249195
• Report Number: 0002249697-2019-02931
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 1236-2-852
• Device Lot Number: 42618501
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR