MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/60; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 1236-2-860

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 09/16/2018

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.The following devices were also listed in this report: restoration (tm) adm.Cup w/ha; cat# 1235-2-601; lot# g3033291.28mm std lfit v40 head; cat# 6260-9-128; lot# 39589102.Size 9 accolade ii 127 deg; cat# 6721-0937; lot# 38971809.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device evaluated by manufacturer? not returned.

Event Description

This patient is a subject in (b)(6) study.At the subject's 6-year follow up visit, he indicated he has pain in his hip due to nerve damage from a lumbar fusion in 2014.He indicated he is overall satisfied with the results of his hip replacement.

• Brand Name: RESTORATION ADM X3 INS 28/60
• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8905770
• MDR Text Key: 154727287
• Report Number: 0002249697-2019-02893
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 04546540639035
• UDI-Public: 04546540639035
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: 1236-2-860
• Device Lot Number: 34450701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 105