MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PRO BONE SPIKE-SHORT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71512449

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/26/2024

Event Type  Injury  

Event Description

It was reported that during a tka revision surgery, when removing the pro bone spike-short from the tibia measurement, it fell into the bone cavity and was not possible to remove.Surgery was completed successfully and the patient was not harmed due to this event.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

• Brand Name: PRO BONE SPIKE-SHORT
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 18927188
• MDR Text Key: 337944269
• Report Number: 1020279-2024-00562
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010223869
• UDI-Public: 03596010223869
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71512449
• Device Lot Number: 18AM01902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Date Device Manufactured: 01/03/2018
• 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
• Patient Outcome(s): Other
• Patient Sex: Female