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

Catalog Number	71324045
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/09/2018
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7727140
• Report Number: 1020279-2018-01346
• Device Sequence Number: 904045
• Product Code: KWY
• UDI-Device Identifier: 03596010494368
• UDI-Public: 03596010494368
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K023743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 71324045
• Device Lot Number: 18EM07135
• Initial Date Received by Manufacturer: 07/10/2018
• Supplement Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 07/27/2018
• Supplement Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention