MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN TRIAL NECK SZ 8-13; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71366408

Device Problem Peeled/Delaminated (1454)

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

Event Date 02/08/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, the magnet of a syn trial neck sz 8-13 appears to be peeling away.As this was noticed in a no-surgical environment, there was not any patient involved.

Manufacturer Narrative

H10: further review of this case indicates this is a duplicate report.The event in this report has been already reported under mdr no.1020279-2022-00911.All further communication for this event will be managed in that case, including a follow up report with the results of our investigation.We respectfully request to close the case as a duplicate and refer to the referenced case above.

• Brand Name: SYN TRIAL NECK SZ 8-13
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13624862
• MDR Text Key: 287284714
• Report Number: 1020279-2022-00906
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010199898
• UDI-Public: 03596010199898
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2010
• Device Model Number: 71366408
• Device Catalogue Number: 71366408
• Device Lot Number: 00102761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1