MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM INTL BIPOLAR 42OD 22ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number 71324042

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Injury (2348)

Event Date 11/16/2018

Event Type  Injury  

Event Description

Dr (b)(6) performed a hemiarthroplasty on his patient using the above implants.Once the hip was reduced he noted that there was no movement between the 22mm femoral head and the tandem shell, effectively negating the benefit of using a bi-polar construct.Even on moving the articulating surface by hand the components were very stiff and resistant to free movement.Revision surgery was performed on (b)(6) 2018.

Manufacturer Narrative

The associated complaint devices were not returned.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.

Manufacturer Narrative

Correct date added.

• Brand Name: TANDEM INTL BIPOLAR 42OD 22ID
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8394723
• MDR Text Key: 137960177
• Report Number: 1020279-2019-00909
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 07611996118674
• UDI-Public: 07611996118674
• Combination Product (y/n): N
• PMA/PMN Number: K023743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71324042
• Device Lot Number: 14GM14216
• Date Manufacturer Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR