MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 28MM +0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number 71342800

Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Markings/Labelling Problem (2911)

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

Event Date 08/17/2021

Event Type  malfunction  

Event Description

It was reported that four (4) oxinium femoral heads 12/14 taper 28mm had manufacturing labels that were cut off and did not fully display the part number, lot number, quantity and expiration date.As this was noticed in a non-surgical environment, there was no patient involvement.

• Brand Name: OXINIUM FEM HD 12/14 28MM +0
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: 12416970
• MDR Text Key: 269827955
• Report Number: 1020279-2021-06697
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 03596010474148
• UDI-Public: 03596010474148
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K021673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2022

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: 71342800
• Device Catalogue Number: 71342800
• Device Lot Number: 21CM16727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/17/2021
• Initial Date FDA Received: 09/02/2021
• Supplement Dates Manufacturer Received: 01/27/2022
• Supplement Dates FDA Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2021
• 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