MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 1236-2-848

Device Problem Insufficient Information (3190)

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

Event Date 08/09/2019

Event Type  Injury  

Manufacturer Narrative

The following devices were also listed in this report: size 3 accolade ii 127 deg; cat#6721-0330; lot#69434502; tridentii tritanium cluster52e; cat#702-04-52e; lot#69888201a; 6.5mm low profile hex screw 25mm; cat#7030-6525; lot#5j3e; 6.5mm low profile hex screw 25mm; cat#7030-6525; lot#5j4; modular dual mobility insert; cat#626-00-42e; lot#70827503; delta un.Fem hd 28mm r28 16/18; cat#6519-1-028; lot#62519802; uni adaptor sleeve v40 ti; cat#6519-t-204; lot#57487001.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not available.

Event Description

Patient was taken back to the operating room (or) to remove a hip implant for infection.This was the second time he was brought back for infection.

• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8964572
• MDR Text Key: 156582670
• Report Number: 0002249697-2019-03085
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 04546540638977
• UDI-Public: 04546540638977
• 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: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1236-2-848
• Device Lot Number: 71438401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2019
• 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