MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM INTL BIPOLAR 45OD 28ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number 71324045

Device Problem Unintended Movement (3026)

Patient Problem Joint Dislocation (2374)

Event Date 07/09/2018

Event Type  Injury  

Event Description

It was reported that after the bipolar surgery, the head was removed from the bipolar cup while the patient was moved on a wheelchair.Three days later a revision surgery was performed.

Manufacturer Narrative

"the associated complaint devices were returned and evaluated.The lab analysis concluded, no damage was observed on the tandem shell/liner construct.Deformation on the inner rim of the poly locking ring was observed.This was likely caused by insertion, removal, or articulation in vivo.The locking ring was disassembled from the bipolar cup/liner construct and examined.Dimensional analysis of the locking ring determined that two dimensions are out of specification, the id and the arc center distance from datum a to the internal sphere.During visual inspection, scratching on the inferior side of the femoral head was observed.This was likely caused during removal or after dissociation.No material or manufacturing deviations were observed in this investigation.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 part revealed no prior complaints for the listed batch.The clinical/medical team concluded, no clinical relevant documents were provided to conduct a thorough medical assessment.No medical assessment is warranted at this time.This complaint will be re-evaluated if more information becomes available.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: TANDEM INTL BIPOLAR 45OD 28ID
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH AND NEPHEW INC; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7727140
• MDR Text Key: 115253345
• Report Number: 1020279-2018-01346
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 03596010494368
• UDI-Public: 03596010494368
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K023743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71324045
• Device Lot Number: 18EM07135
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2018
• Initial Date FDA Received: 07/27/2018
• Supplement Dates Manufacturer Received: 07/10/2018
• Supplement Dates FDA Received: 01/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention