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

Catalog Number	71324042
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/16/2018
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
Correct date added.

• Brand Name: TANDEM INTL BIPOLAR 42OD 22ID
• 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: 8394723
• Report Number: 1020279-2019-00909
• Device Sequence Number: 240476
• Product Code: KWY
• UDI-Device Identifier: 07611996118674
• UDI-Public: 07611996118674
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,Followup
• Report Date (Section B): 05/24/2019

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 Expiration Date: 07/19/2024
• Device Catalogue Number: 71324042
• Device Lot Number: 14GM14216
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 02/25/2019; 02/25/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 03/06/2019; 05/24/2019
• 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
• Patient Age: 84 YR