MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/58; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 1236-2-858

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 11/19/2019

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: delta v-40 ceramic head 28/+4; cat# 6570-0-228 ; lot# 66768702.Mod con dist stem 14 x 155 mm; cat# 6276-7-014; lot# caxx900a.21mm mod rev hip body/bolt std component level 9006-1-021; cat# 6276-1-021; lot# 71134801 modular dual mobility insert; cat# 626-00-52h; lot# 69528702.Trident ii tritanium multi 64h; cat# 709-04-64h; lot# 72256201a.6.5mm low profile hex screw 25mm; cat# 7030-6525; lot# 5m4.6.5mm low profile hex screw 15mm; cat# 7030-6515; lot# 5x4.6.5mm low profile hex screw 15mm; cat# 7030-6515; lot# 6vw.6.5mm low profile hex screw 25mm; cat# 7030-6525; lot# 6cye.6.5mm low profile hex screw 25mm; cat# 7030-6525; lot# 4tua.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

As reported "surgeon did a head exchange due to possible infection.X-ray, original [usage] sheet, revision.[usage] sheet all attached.No other information available per hospital policy." the femoral head and adm/ mdm insert were revised.

• Brand Name: RESTORATION ADM X3 INS 28/58
• 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: 9484893
• MDR Text Key: 185031062
• Report Number: 0002249697-2019-04041
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 04546540639028
• UDI-Public: 04546540639028
• 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: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 1236-2-858
• Device Lot Number: 50338301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 69 YR