MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIB BASE LM/RL SZ 6; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71422226

Device Problem Fracture (1260)

Patient Problems Pain (1994); Swelling (2091); Injury (2348)

Event Date 01/26/2016

Event Type  Injury  

Event Description

It was reported the patient presented on (b)(6) 2014 with pain and swelling in his left knee.X-rays were performed and were unremarkable.On (b)(6) 2015, the pain and swelling returned and x-rays were performed again and showed a fractured baseplate.A revision surgery was performed due to the fractured baseplate.

Manufacturer Narrative

The associated device was not returned for evaluation.No medical/clinical assessment could be performed due to the lack of patient information being provided.On december 23, 2009, smith & nephew initiated a voluntary recall of all lots of journey uni tibial baseplates.The clinical analysis concluded that the clinical findings of the pain experienced by this patient, and the observations during the revision are consistent with an adverse reaction to metal wear associated with metal on metal products with the source likely due to the broken plate and associated wear and abrasion but this cannot be confirmed without the components and xrays.It should be noted that the hhe and the field action strategy cited the base-plate breakage as an issue.It is also unknown; if the combination of components contributed to the metal on metal wear and the deformity of the insert or the patient¿s body habitus with a bmi of 38.8 played a role in the fractured base-plate.Corrective actions were implemented to prevent recurrence of this failure mode.No further actions are being taken at this time.Should additional information be received, the complaint will be reopened.We will continue to monitor for future complaints.

• Brand Name: JOURNEY UNI TIB BASE LM/RL SZ 6
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: markus poettker ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 6910925
• MDR Text Key: 88030533
• Report Number: 1020279-2017-00820
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2018
• Device Catalogue Number: 71422226
• Device Lot Number: 08FM05276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/07/2008
• 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
• Treatment: FEMORAL COMP PART#71422346 LOT#08JM05954; INSERT PART#71422261 LOT#08GM07178
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR