MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HIGH FLEX IMPCTR HD 3-8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 71441554

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2020

Event Type  malfunction  

Event Description

It was reported that during a consignment inspection the device was found burrs/nicks/scratches/gouges.The device will be returned.Upon visual inspection, it was the device was noticed cracked.

• Brand Name: GII PS HIGH FLEX IMPCTR HD 3-8
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11797058
• MDR Text Key: 249688847
• Report Number: 1020279-2021-03901
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010497376
• UDI-Public: 03596010497376
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71441554
• Device Catalogue Number: 71441554
• Device Lot Number: 11BM09068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/22/2021
• Initial Date FDA Received: 05/10/2021
• Supplement Dates Manufacturer Received: 04/22/2021
• Supplement Dates FDA Received: 05/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2011
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1